Establishment Registration & Device Listing

1 result found for Establishment Registration or FEI Number : 1218950 Owner Operator Number : 1217116

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Establishment
Name

Registration Number

Current
Registration Yr

Philips North America LLC

MA/USA

1218950

2024

cable, electrode - 989803157481, DigiTrak XT Patient Cable, short; 989803157491, DigiTrak XT Patient Cable, Medium; 989803157501, DigiTrak XT Patient Cable, Long; BTP-1000A-Hybrid Patch; BTP-1000L-2-Lead Wire Adapter; CBL 5 Lead, Snap, Shld, AAMI, Chest, Rgd - 989803176171; CBL 5 Lead, Snap, Shld, AAMI, Limb, Rgd - 989803176161; CBL 5 Lead, Snap, Shld, IEC, Limb, Rgd - 989803176181; EEG Leadset - 989803180521; EEG Leadset - 989803180531; EEG Leadset - 989803180541; EEG Leadset - 989803180561; Flex Adapter; Lead Wire Adapter; M1532A ECG Cable; M1533A ECG Cable; M1602A ECG Cable; M1624A ECG Cable; M1626A ECG Cable; M1644A ECG Cable; M1645A ECG Cable; M1663A ECG Trunk Cable; M1665A ECG Trunk Cable; M1667A ECG Trunk Cable; M1668A ECG Trunk Cable; M1669A ECG Trunk Cable; M1671A ECG Cable; M1672A ECG Cable; M1673A ECG Cable; M1674A ECG Cable; M1675A ECG Cable; M1678A ECG Cable; M1680A ECG Cable; M1681A ECG Cable; M1934A EEG Leadset; M1949A ECG Trunk Cable; M1968A ECG Cable; M1971A ECG Cable; M1973A ECG Cable; M1974A ECG Cable; M1976A ECG Cable; M1978A ECG Cable; M1979A ECG Cable; M2268A EEG Trunk Cable; OMNI-TRAK 3000 SERIES

Specification Developer

antimicrobial blood pressure cuff - 989803182281 Single Care Cuff, Pediatric; 989803182291 Single Care Cuff, Small Adult; 989803182301 Single Care Cuff, Adult; 989803182311 Single Care Cuff, Adult XL; 989803182321 Single Care Cuff, Large Adult

Specification Developer

electrode, electrocardiograph - 40420A HI-Tack Foam Wet Gel ECG Electrode; 989803101301 HI-Tack Foam Wet Gel ECG Electrode; Snap Style Foam Electrode

Repackager/Relabeler; Complaint File Establishment

monitor, blood-gas, on-line, cardiopulmonary bypass - Blood pressure monitor

Specification Developer

transmitters and receivers, electrocardiograph, telephone - Telemetry Monitoring System

Specification Developer

electrocardiograph, ambulatory (without analysis) - DigiTrak XT Holter Recorder w/Leadwires; DigiTrak XT Recorder; DL800 Holter System; DL950 Holter System

Specification Developer

gas-machine, anesthesia - CompuRecord System

Complaint File Establishment

detector and alarm, arrhythmia - Philips ST/AR ST

Specification Developer

monitor, physiological, patient(with arrhythmia detection or alarms) - Philips ST/AR ST

Specification Developer

monitor, st segment with alarm - Philips ST/AR ST

Specification Developer

blood pressure cuff - 989803167541 Neonatal Single-Patient NIBP Cuffs; 989803167551 Neonatal Soft Single-Patient NIBP Cuffs; M1866B Neonatal Single-Patient Cuff Size #1; M1866S Neonatal Soft Single-Patient Cuff Size#1; M1868B Neonatal Single-Patient Cuff Size #2; M1868S Neonatal Soft Single-Patient Cuff Size#2; M1870B Neonatal Single-Patient Cuff Size #3; M1870S Neonatal Soft Single-Patient Cuff Size#3; M1872B Neonatal Single-Patient Cuff Size #4; M1872S Neonatal Soft Single-Patient Cuff Size#4; M1873B Infant Single-Patient Cuff Size #5; M1873S Infant Soft Single-Patient Cuff Size #5

Specification Developer

monitor, physiological, patient(with arrhythmia detection or alarms) - 989803171811 ECG 3 lead Grabber, AAMI + SpO2, Tele; 989803171821 ECG 5 lead Snaps, AAMI, Tele; 989803171831 ECG 5 lead Grabber, AAMI, Tele; 989803171841 ECG 5 lead Snaps, AAMI + SpO2, Tele; 989803171851 ECG 5 lead Grabber, AAMI + SpO2, Tele; 989803171861 ECG 6 lead Grabber, AAMI, Tele; 989803171911 ECG 3 lead Grabber, IEC + SpO2, Tele; 989803171931 ECG 5 lead Grabber, IEC, Tele; 989803171951 ECG 5 lead Grabber, IEC + SpO2, Tele; 989803171961 ECG 6 lead Grabber, IEC, Tele; 989803171971 CBL ECG 6 Lead Grabber, IEC+SpO2, Tele; 989803199071 ECG 6 lead Grabber, IEC + SpO2, Tele; 989803199081 MX40 Adapter SpO2-only; 989803199091 MX40 Adapter 5L+SpO2; 989803199101 MX40 Adapter 3L+SpO2; INTELLIVUE MX40 PATIENT MONITOR

Specification Developer

computer, diagnostic, programmable - IntelliSpace ECG; IntelliSpace ECG SW

Specification Developer

computer, diagnostic, programmable - 989803180121, ST80i 12-Lead Complete Lead Set (AAMI), Standard Length, Grabber; 989803180131, ST80i 12-Lead Complete Lead Set (IEC), Standard Length, Grabber; 989803180141, ST80i 12-Lead Complete Lead Set (AAMI), Standard Length, Snaps; 989803180151, ST80i 12-Lead Complete Lead Set (IEC), Standard Length, Snaps; ST80i Stress Test System; ST80i Stress Test System w/ Printer, Lead Sets, Electrodes

Specification Developer

bilirubin (total and unbound) in the neonate test system - 1037632 Bilichek (Advanced); B800-500 BiliCal; 50 Pack

Specification Developer

oximeter - SureSigns VS Temporal Temperature HH - 989803192931

Specification Developer

cable, transducer and electrode, patient, (including connector) - SureSigns VS Temporal Temperature HH - 989803192931

Specification Developer

alarm, blood-pressure - SureSigns VS Temporal Temperature HH - 989803192931

Specification Developer

computer, blood-pressure - SureSigns VS Temporal Temperature HH - 989803192931

Specification Developer

system, measurement, blood-pressure, non-invasive - SureSigns VS Temporal Temperature HH - 989803192931

Specification Developer

thermometer, electronic, clinical - SureSigns VS Temporal Temperature HH - 989803192931

Specification Developer

detector and alarm, arrhythmia - 989803183311 Multi Care Cuff, Infant; 989803183321 Multi Care Cuff, Pediatric; 989803183331 Multi Care Cuff, Small Adult; 989803183341 Multi Care Cuff, Adult; 989803183351 Multi Care Cuff, Adult XL; 989803183361Multi Care Cuff, Large Adult; 989803183371 Multi Care Cuff, Thigh; M1571A Comfort Care Cuff, Infant; M1572A Comfort Care Cuff, Pediatric; M1573A Comfort Care Cuff, Small Adult; M1574A Comfort Care Cuff, Adult; M1574XL Comfort Care Cuff, Adult XL; M1575A Comfort Care Cuff, Large Adult; M1576A Comfort Care Cuff, Thigh

Specification Developer

oximeter - 989803172031 SPU ECG Lead Set, 5 Lead, AAMI, Grabber; 989803172051 ECG 5 lead Graber, AAMI + SpO2, SPU, Tele; 989803172131 SPU ECG Lead Set, 5 Lead, AAMI, Grabber; 989803172151 ECG 5 lead Grabber, IEC + SpO2,SPU,Tele; 989803172221 ECG 5L Grabber, AAMI, SpO2, Tele; Intellivue MX40 Patient Monitor

Specification Developer

transmitters and receivers, physiological signal, radiofrequency - 989803172031 SPU ECG Lead Set, 5 Lead, AAMI, Grabber; 989803172051 ECG 5 lead Graber, AAMI + SpO2, SPU, Tele; 989803172131 SPU ECG Lead Set, 5 Lead, AAMI, Grabber; 989803172151 ECG 5 lead Grabber, IEC + SpO2,SPU,Tele; 989803172221 ECG 5L Grabber, AAMI, SpO2, Tele; Intellivue MX40 Patient Monitor

Specification Developer

adaptor, lead switching, electrocardiograph - 989803172031 SPU ECG Lead Set, 5 Lead, AAMI, Grabber; 989803172051 ECG 5 lead Graber, AAMI + SpO2, SPU, Tele; 989803172131 SPU ECG Lead Set, 5 Lead, AAMI, Grabber; 989803172151 ECG 5 lead Grabber, IEC + SpO2,SPU,Tele; 989803172221 ECG 5L Grabber, AAMI, SpO2, Tele; Intellivue MX40 Patient Monitor

Specification Developer

cable, transducer and electrode, patient, (including connector) - 989803172031 SPU ECG Lead Set, 5 Lead, AAMI, Grabber; 989803172051 ECG 5 lead Graber, AAMI + SpO2, SPU, Tele; 989803172131 SPU ECG Lead Set, 5 Lead, AAMI, Grabber; 989803172151 ECG 5 lead Grabber, IEC + SpO2,SPU,Tele; 989803172221 ECG 5L Grabber, AAMI, SpO2, Tele; Intellivue MX40 Patient Monitor

Specification Developer

detector and alarm, arrhythmia - 989803172031 SPU ECG Lead Set, 5 Lead, AAMI, Grabber; 989803172051 ECG 5 lead Graber, AAMI + SpO2, SPU, Tele; 989803172131 SPU ECG Lead Set, 5 Lead, AAMI, Grabber; 989803172151 ECG 5 lead Grabber, IEC + SpO2,SPU,Tele; 989803172221 ECG 5L Grabber, AAMI, SpO2, Tele; Intellivue MX40 Patient Monitor

Specification Developer

monitor, physiological, patient(with arrhythmia detection or alarms) - 989803172031 SPU ECG Lead Set, 5 Lead, AAMI, Grabber; 989803172051 ECG 5 lead Graber, AAMI + SpO2, SPU, Tele; 989803172131 SPU ECG Lead Set, 5 Lead, AAMI, Grabber; 989803172151 ECG 5 lead Grabber, IEC + SpO2,SPU,Tele; 989803172221 ECG 5L Grabber, AAMI, SpO2, Tele; Intellivue MX40 Patient Monitor

Specification Developer

monitor, st segment with alarm - 989803172031 SPU ECG Lead Set, 5 Lead, AAMI, Grabber; 989803172051 ECG 5 lead Graber, AAMI + SpO2, SPU, Tele; 989803172131 SPU ECG Lead Set, 5 Lead, AAMI, Grabber; 989803172151 ECG 5 lead Grabber, IEC + SpO2,SPU,Tele; 989803172221 ECG 5L Grabber, AAMI, SpO2, Tele; Intellivue MX40 Patient Monitor

Specification Developer

system, network and communication, physiological monitors - 989803172031 SPU ECG Lead Set, 5 Lead, AAMI, Grabber; 989803172051 ECG 5 lead Graber, AAMI + SpO2, SPU, Tele; 989803172131 SPU ECG Lead Set, 5 Lead, AAMI, Grabber; 989803172151 ECG 5 lead Grabber, IEC + SpO2,SPU,Tele; 989803172221 ECG 5L Grabber, AAMI, SpO2, Tele; Intellivue MX40 Patient Monitor

Specification Developer

analyzer, gas, carbon-dioxide, gaseous-phase - 863286, SureSigns VS4 Government Bundle; 989803180831, Genius 2 tympanic temperature probe; 989803192931, SureSigns VS Temporal Temperature HH

Specification Developer

alarm, blood-pressure - 863286, SureSigns VS4 Government Bundle; 989803180831, Genius 2 tympanic temperature probe; 989803192931, SureSigns VS Temporal Temperature HH

Specification Developer

computer, blood-pressure - 863286, SureSigns VS4 Government Bundle; 989803180831, Genius 2 tympanic temperature probe; 989803192931, SureSigns VS Temporal Temperature HH

Specification Developer

thermometer, electronic, clinical - 863286, SureSigns VS4 Government Bundle; 989803180831, Genius 2 tympanic temperature probe; 989803192931, SureSigns VS Temporal Temperature HH

Specification Developer

tape and bandage, adhesive - B800-11 BilEclipse, 50 Pack

Specification Developer

electrocardiograph, ambulatory, with analysis algorithm - Holter 1810/ 2010 SW

Specification Developer

system, network and communication, physiological monitors - Philips IntelliVue Information Center iX, M3290B Software

Specification Developer

oximeter - 989803163181 Mobile CL Disposable Small Adult Cuff; 989803163191 Mobile CL Reusable Adult Cuff; 989803163201 Mobile CL Disposable Adult Cuff; 989803163211 Mobile CL Reusable Large Adult Cuff; 989803163221 Mobile CL Disposable Large Adult Cuff; 989803163251 Mobile CL NBP Cradle Kit; 989803168881 Mobile CL Transmitter Cradles; Diverse Specialized Accessories and IntelliVue CL 865220 charging station; IntelliVue CL SpO2 Pod, CL NBP Pod SW Rev. A.0; IntelliVue Multi-Measurement Module X2, SW Rev. H.01; IntelliVue Patient Monitor MP5, MP5T, MP2, SW Rev. H.01; IntelliVue Telemetry System Transceiver TRx4841A, SW Rev. D.0

Specification Developer

transmitters and receivers, physiological signal, radiofrequency - 989803163181 Mobile CL Disposable Small Adult Cuff; 989803163191 Mobile CL Reusable Adult Cuff; 989803163201 Mobile CL Disposable Adult Cuff; 989803163211 Mobile CL Reusable Large Adult Cuff; 989803163221 Mobile CL Disposable Large Adult Cuff; 989803163251 Mobile CL NBP Cradle Kit; 989803168881 Mobile CL Transmitter Cradles; Diverse Specialized Accessories and IntelliVue CL 865220 charging station; IntelliVue CL SpO2 Pod, CL NBP Pod SW Rev. A.0; IntelliVue Multi-Measurement Module X2, SW Rev. H.01; IntelliVue Patient Monitor MP5, MP5T, MP2, SW Rev. H.01; IntelliVue Telemetry System Transceiver TRx4841A, SW Rev. D.0

Specification Developer

amplifier and signal conditioner, transducer signal - 989803163181 Mobile CL Disposable Small Adult Cuff; 989803163191 Mobile CL Reusable Adult Cuff; 989803163201 Mobile CL Disposable Adult Cuff; 989803163211 Mobile CL Reusable Large Adult Cuff; 989803163221 Mobile CL Disposable Large Adult Cuff; 989803163251 Mobile CL NBP Cradle Kit; 989803168881 Mobile CL Transmitter Cradles; Diverse Specialized Accessories and IntelliVue CL 865220 charging station; IntelliVue CL SpO2 Pod, CL NBP Pod SW Rev. A.0; IntelliVue Multi-Measurement Module X2, SW Rev. H.01; IntelliVue Patient Monitor MP5, MP5T, MP2, SW Rev. H.01; IntelliVue Telemetry System Transceiver TRx4841A, SW Rev. D.0

Specification Developer

monitor, cardiac (incl. cardiotachometer & rate alarm) - 989803163181 Mobile CL Disposable Small Adult Cuff; 989803163191 Mobile CL Reusable Adult Cuff; 989803163201 Mobile CL Disposable Adult Cuff; 989803163211 Mobile CL Reusable Large Adult Cuff; 989803163221 Mobile CL Disposable Large Adult Cuff; 989803163251 Mobile CL NBP Cradle Kit; 989803168881 Mobile CL Transmitter Cradles; Diverse Specialized Accessories and IntelliVue CL 865220 charging station; IntelliVue CL SpO2 Pod, CL NBP Pod SW Rev. A.0; IntelliVue Multi-Measurement Module X2, SW Rev. H.01; IntelliVue Patient Monitor MP5, MP5T, MP2, SW Rev. H.01; IntelliVue Telemetry System Transceiver TRx4841A, SW Rev. D.0

Specification Developer

cable, transducer and electrode, patient, (including connector) - 989803163181 Mobile CL Disposable Small Adult Cuff; 989803163191 Mobile CL Reusable Adult Cuff; 989803163201 Mobile CL Disposable Adult Cuff; 989803163211 Mobile CL Reusable Large Adult Cuff; 989803163221 Mobile CL Disposable Large Adult Cuff; 989803163251 Mobile CL NBP Cradle Kit; 989803168881 Mobile CL Transmitter Cradles; Diverse Specialized Accessories and IntelliVue CL 865220 charging station; IntelliVue CL SpO2 Pod, CL NBP Pod SW Rev. A.0; IntelliVue Multi-Measurement Module X2, SW Rev. H.01; IntelliVue Patient Monitor MP5, MP5T, MP2, SW Rev. H.01; IntelliVue Telemetry System Transceiver TRx4841A, SW Rev. D.0

Specification Developer

detector and alarm, arrhythmia - 989803163181 Mobile CL Disposable Small Adult Cuff; 989803163191 Mobile CL Reusable Adult Cuff; 989803163201 Mobile CL Disposable Adult Cuff; 989803163211 Mobile CL Reusable Large Adult Cuff; 989803163221 Mobile CL Disposable Large Adult Cuff; 989803163251 Mobile CL NBP Cradle Kit; 989803168881 Mobile CL Transmitter Cradles; Diverse Specialized Accessories and IntelliVue CL 865220 charging station; IntelliVue CL SpO2 Pod, CL NBP Pod SW Rev. A.0; IntelliVue Multi-Measurement Module X2, SW Rev. H.01; IntelliVue Patient Monitor MP5, MP5T, MP2, SW Rev. H.01; IntelliVue Telemetry System Transceiver TRx4841A, SW Rev. D.0

Specification Developer

alarm, blood-pressure - 989803163181 Mobile CL Disposable Small Adult Cuff; 989803163191 Mobile CL Reusable Adult Cuff; 989803163201 Mobile CL Disposable Adult Cuff; 989803163211 Mobile CL Reusable Large Adult Cuff; 989803163221 Mobile CL Disposable Large Adult Cuff; 989803163251 Mobile CL NBP Cradle Kit; 989803168881 Mobile CL Transmitter Cradles; Diverse Specialized Accessories and IntelliVue CL 865220 charging station; IntelliVue CL SpO2 Pod, CL NBP Pod SW Rev. A.0; IntelliVue Multi-Measurement Module X2, SW Rev. H.01; IntelliVue Patient Monitor MP5, MP5T, MP2, SW Rev. H.01; IntelliVue Telemetry System Transceiver TRx4841A, SW Rev. D.0

Specification Developer

computer, blood-pressure - 989803163181 Mobile CL Disposable Small Adult Cuff; 989803163191 Mobile CL Reusable Adult Cuff; 989803163201 Mobile CL Disposable Adult Cuff; 989803163211 Mobile CL Reusable Large Adult Cuff; 989803163221 Mobile CL Disposable Large Adult Cuff; 989803163251 Mobile CL NBP Cradle Kit; 989803168881 Mobile CL Transmitter Cradles; Diverse Specialized Accessories and IntelliVue CL 865220 charging station; IntelliVue CL SpO2 Pod, CL NBP Pod SW Rev. A.0; IntelliVue Multi-Measurement Module X2, SW Rev. H.01; IntelliVue Patient Monitor MP5, MP5T, MP2, SW Rev. H.01; IntelliVue Telemetry System Transceiver TRx4841A, SW Rev. D.0

Specification Developer

computer, diagnostic, pre-programmed, single-function - 989803163181 Mobile CL Disposable Small Adult Cuff; 989803163191 Mobile CL Reusable Adult Cuff; 989803163201 Mobile CL Disposable Adult Cuff; 989803163211 Mobile CL Reusable Large Adult Cuff; 989803163221 Mobile CL Disposable Large Adult Cuff; 989803163251 Mobile CL NBP Cradle Kit; 989803168881 Mobile CL Transmitter Cradles; Diverse Specialized Accessories and IntelliVue CL 865220 charging station; IntelliVue CL SpO2 Pod, CL NBP Pod SW Rev. A.0; IntelliVue Multi-Measurement Module X2, SW Rev. H.01; IntelliVue Patient Monitor MP5, MP5T, MP2, SW Rev. H.01; IntelliVue Telemetry System Transceiver TRx4841A, SW Rev. D.0

Specification Developer

system, measurement, blood-pressure, non-invasive - 989803163181 Mobile CL Disposable Small Adult Cuff; 989803163191 Mobile CL Reusable Adult Cuff; 989803163201 Mobile CL Disposable Adult Cuff; 989803163211 Mobile CL Reusable Large Adult Cuff; 989803163221 Mobile CL Disposable Large Adult Cuff; 989803163251 Mobile CL NBP Cradle Kit; 989803168881 Mobile CL Transmitter Cradles; Diverse Specialized Accessories and IntelliVue CL 865220 charging station; IntelliVue CL SpO2 Pod, CL NBP Pod SW Rev. A.0; IntelliVue Multi-Measurement Module X2, SW Rev. H.01; IntelliVue Patient Monitor MP5, MP5T, MP2, SW Rev. H.01; IntelliVue Telemetry System Transceiver TRx4841A, SW Rev. D.0

Specification Developer

blood pressure cuff - 989803163181 Mobile CL Disposable Small Adult Cuff; 989803163191 Mobile CL Reusable Adult Cuff; 989803163201 Mobile CL Disposable Adult Cuff; 989803163211 Mobile CL Reusable Large Adult Cuff; 989803163221 Mobile CL Disposable Large Adult Cuff; 989803163251 Mobile CL NBP Cradle Kit; 989803168881 Mobile CL Transmitter Cradles; Diverse Specialized Accessories and IntelliVue CL 865220 charging station; IntelliVue CL SpO2 Pod, CL NBP Pod SW Rev. A.0; IntelliVue Multi-Measurement Module X2, SW Rev. H.01; IntelliVue Patient Monitor MP5, MP5T, MP2, SW Rev. H.01; IntelliVue Telemetry System Transceiver TRx4841A, SW Rev. D.0

Specification Developer

monitor, physiological, patient(with arrhythmia detection or alarms) - 989803163181 Mobile CL Disposable Small Adult Cuff; 989803163191 Mobile CL Reusable Adult Cuff; 989803163201 Mobile CL Disposable Adult Cuff; 989803163211 Mobile CL Reusable Large Adult Cuff; 989803163221 Mobile CL Disposable Large Adult Cuff; 989803163251 Mobile CL NBP Cradle Kit; 989803168881 Mobile CL Transmitter Cradles; Diverse Specialized Accessories and IntelliVue CL 865220 charging station; IntelliVue CL SpO2 Pod, CL NBP Pod SW Rev. A.0; IntelliVue Multi-Measurement Module X2, SW Rev. H.01; IntelliVue Patient Monitor MP5, MP5T, MP2, SW Rev. H.01; IntelliVue Telemetry System Transceiver TRx4841A, SW Rev. D.0

Specification Developer

system, network and communication, physiological monitors - 989803163181 Mobile CL Disposable Small Adult Cuff; 989803163191 Mobile CL Reusable Adult Cuff; 989803163201 Mobile CL Disposable Adult Cuff; 989803163211 Mobile CL Reusable Large Adult Cuff; 989803163221 Mobile CL Disposable Large Adult Cuff; 989803163251 Mobile CL NBP Cradle Kit; 989803168881 Mobile CL Transmitter Cradles; Diverse Specialized Accessories and IntelliVue CL 865220 charging station; IntelliVue CL SpO2 Pod, CL NBP Pod SW Rev. A.0; IntelliVue Multi-Measurement Module X2, SW Rev. H.01; IntelliVue Patient Monitor MP5, MP5T, MP2, SW Rev. H.01; IntelliVue Telemetry System Transceiver TRx4841A, SW Rev. D.0

Specification Developer

system, monitoring, perinatal - M1562B Reusable abdominal/leg belt- 50mm X 1.3M; M2208A Disposable abdominal belts,100/cs; M4601A Reusable Leg Belt- 32mm X 15M; M4602A Reusable Abdominal Belt- 60mm Wd,1.3M Lg; M4603A Reusable Abdominal Belt- 60mm Wd, 15M LG

Specification Developer

electrocardiograph - CBL OR 3-Lead ECG Trunk Cable, AAMI/IEC - 989803170171; CBL OR 5-Lead ECG Trunk Cable, AAMI/IEC - 989803170181

Specification Developer

display, cathode-ray tube, medical - Clinical Analytics Platform Engine B.0; Clinical Analytics Platform Engine B.0 – Upgrade; CS770 IntelliSpace Critical Care and Anesthesia H.0; IntelliSpace Console Critical Care User Interface B.0; IntelliSpace Console Critical Care User Interface B.0 - Upgrade

Specification Developer

oximeter - MX40 Release B.07

Specification Developer

transmitters and receivers, physiological signal, radiofrequency - MX40 Release B.07

Specification Developer

adaptor, lead switching, electrocardiograph - MX40 Release B.07

Specification Developer

cable, transducer and electrode, patient, (including connector) - MX40 Release B.07

Specification Developer

detector and alarm, arrhythmia - MX40 Release B.07

Specification Developer

monitor, physiological, patient(with arrhythmia detection or alarms) - MX40 Release B.07

Specification Developer

monitor, st segment with alarm - MX40 Release B.07

Specification Developer

system, network and communication, physiological monitors - MX40 Release B.07

Specification Developer

oximeter - Avalon Basestation (866074); Avalon CL Fetal & Maternal Pod (866488); Avalon Fetal & Maternal Patch; Avalon Fetal/Maternal Monitors FM20 (M2702A), FM30 (M2703A), FM40 (M2704A) and FM50 (M2705A); Avalon Patient Module (M2738A); M2734B; MECG Adapter Cable (M1363A); Remote Event Marker (989803143411); Transducers (866075, 866076, 866077, 867245, 867246, 867247, 867248, 867249, M2735A, M2736A, M2736AA)

Specification Developer

transmitters and receivers, physiological signal, radiofrequency - Avalon Basestation (866074); Avalon CL Fetal & Maternal Pod (866488); Avalon Fetal & Maternal Patch; Avalon Fetal/Maternal Monitors FM20 (M2702A), FM30 (M2703A), FM40 (M2704A) and FM50 (M2705A); Avalon Patient Module (M2738A); M2734B; MECG Adapter Cable (M1363A); Remote Event Marker (989803143411); Transducers (866075, 866076, 866077, 867245, 867246, 867247, 867248, 867249, M2735A, M2736A, M2736AA)

Specification Developer

amplifier and signal conditioner, transducer signal - Avalon Basestation (866074); Avalon CL Fetal & Maternal Pod (866488); Avalon Fetal & Maternal Patch; Avalon Fetal/Maternal Monitors FM20 (M2702A), FM30 (M2703A), FM40 (M2704A) and FM50 (M2705A); Avalon Patient Module (M2738A); M2734B; MECG Adapter Cable (M1363A); Remote Event Marker (989803143411); Transducers (866075, 866076, 866077, 867245, 867246, 867247, 867248, 867249, M2735A, M2736A, M2736AA)

Specification Developer

transducer, blood-pressure, extravascular - Avalon Basestation (866074); Avalon CL Fetal & Maternal Pod (866488); Avalon Fetal & Maternal Patch; Avalon Fetal/Maternal Monitors FM20 (M2702A), FM30 (M2703A), FM40 (M2704A) and FM50 (M2705A); Avalon Patient Module (M2738A); M2734B; MECG Adapter Cable (M1363A); Remote Event Marker (989803143411); Transducers (866075, 866076, 866077, 867245, 867246, 867247, 867248, 867249, M2735A, M2736A, M2736AA)

Specification Developer

monitor, cardiac (incl. cardiotachometer & rate alarm) - Avalon Basestation (866074); Avalon CL Fetal & Maternal Pod (866488); Avalon Fetal & Maternal Patch; Avalon Fetal/Maternal Monitors FM20 (M2702A), FM30 (M2703A), FM40 (M2704A) and FM50 (M2705A); Avalon Patient Module (M2738A); M2734B; MECG Adapter Cable (M1363A); Remote Event Marker (989803143411); Transducers (866075, 866076, 866077, 867245, 867246, 867247, 867248, 867249, M2735A, M2736A, M2736AA)

Specification Developer

cable, transducer and electrode, patient, (including connector) - Avalon Basestation (866074); Avalon CL Fetal & Maternal Pod (866488); Avalon Fetal & Maternal Patch; Avalon Fetal/Maternal Monitors FM20 (M2702A), FM30 (M2703A), FM40 (M2704A) and FM50 (M2705A); Avalon Patient Module (M2738A); M2734B; MECG Adapter Cable (M1363A); Remote Event Marker (989803143411); Transducers (866075, 866076, 866077, 867245, 867246, 867247, 867248, 867249, M2735A, M2736A, M2736AA)

Specification Developer

recorder, paper chart - Avalon Basestation (866074); Avalon CL Fetal & Maternal Pod (866488); Avalon Fetal & Maternal Patch; Avalon Fetal/Maternal Monitors FM20 (M2702A), FM30 (M2703A), FM40 (M2704A) and FM50 (M2705A); Avalon Patient Module (M2738A); M2734B; MECG Adapter Cable (M1363A); Remote Event Marker (989803143411); Transducers (866075, 866076, 866077, 867245, 867246, 867247, 867248, 867249, M2735A, M2736A, M2736AA)

Specification Developer

detector and alarm, arrhythmia - Avalon Basestation (866074); Avalon CL Fetal & Maternal Pod (866488); Avalon Fetal & Maternal Patch; Avalon Fetal/Maternal Monitors FM20 (M2702A), FM30 (M2703A), FM40 (M2704A) and FM50 (M2705A); Avalon Patient Module (M2738A); M2734B; MECG Adapter Cable (M1363A); Remote Event Marker (989803143411); Transducers (866075, 866076, 866077, 867245, 867246, 867247, 867248, 867249, M2735A, M2736A, M2736AA)

Specification Developer

alarm, blood-pressure - Avalon Basestation (866074); Avalon CL Fetal & Maternal Pod (866488); Avalon Fetal & Maternal Patch; Avalon Fetal/Maternal Monitors FM20 (M2702A), FM30 (M2703A), FM40 (M2704A) and FM50 (M2705A); Avalon Patient Module (M2738A); M2734B; MECG Adapter Cable (M1363A); Remote Event Marker (989803143411); Transducers (866075, 866076, 866077, 867245, 867246, 867247, 867248, 867249, M2735A, M2736A, M2736AA)

Specification Developer

computer, blood-pressure - Avalon Basestation (866074); Avalon CL Fetal & Maternal Pod (866488); Avalon Fetal & Maternal Patch; Avalon Fetal/Maternal Monitors FM20 (M2702A), FM30 (M2703A), FM40 (M2704A) and FM50 (M2705A); Avalon Patient Module (M2738A); M2734B; MECG Adapter Cable (M1363A); Remote Event Marker (989803143411); Transducers (866075, 866076, 866077, 867245, 867246, 867247, 867248, 867249, M2735A, M2736A, M2736AA)

Specification Developer

computer, diagnostic, pre-programmed, single-function - Avalon Basestation (866074); Avalon CL Fetal & Maternal Pod (866488); Avalon Fetal & Maternal Patch; Avalon Fetal/Maternal Monitors FM20 (M2702A), FM30 (M2703A), FM40 (M2704A) and FM50 (M2705A); Avalon Patient Module (M2738A); M2734B; MECG Adapter Cable (M1363A); Remote Event Marker (989803143411); Transducers (866075, 866076, 866077, 867245, 867246, 867247, 867248, 867249, M2735A, M2736A, M2736AA)

Specification Developer

system, measurement, blood-pressure, non-invasive - Avalon Basestation (866074); Avalon CL Fetal & Maternal Pod (866488); Avalon Fetal & Maternal Patch; Avalon Fetal/Maternal Monitors FM20 (M2702A), FM30 (M2703A), FM40 (M2704A) and FM50 (M2705A); Avalon Patient Module (M2738A); M2734B; MECG Adapter Cable (M1363A); Remote Event Marker (989803143411); Transducers (866075, 866076, 866077, 867245, 867246, 867247, 867248, 867249, M2735A, M2736A, M2736AA)

Specification Developer

blood pressure cuff - Avalon Basestation (866074); Avalon CL Fetal & Maternal Pod (866488); Avalon Fetal & Maternal Patch; Avalon Fetal/Maternal Monitors FM20 (M2702A), FM30 (M2703A), FM40 (M2704A) and FM50 (M2705A); Avalon Patient Module (M2738A); M2734B; MECG Adapter Cable (M1363A); Remote Event Marker (989803143411); Transducers (866075, 866076, 866077, 867245, 867246, 867247, 867248, 867249, M2735A, M2736A, M2736AA)

Specification Developer

thermometer, electronic, clinical - Avalon Basestation (866074); Avalon CL Fetal & Maternal Pod (866488); Avalon Fetal & Maternal Patch; Avalon Fetal/Maternal Monitors FM20 (M2702A), FM30 (M2703A), FM40 (M2704A) and FM50 (M2705A); Avalon Patient Module (M2738A); M2734B; MECG Adapter Cable (M1363A); Remote Event Marker (989803143411); Transducers (866075, 866076, 866077, 867245, 867246, 867247, 867248, 867249, M2735A, M2736A, M2736AA)

Specification Developer

monitor, uterine contraction, external (for use in clinic) - Avalon Basestation (866074); Avalon CL Fetal & Maternal Pod (866488); Avalon Fetal & Maternal Patch; Avalon Fetal/Maternal Monitors FM20 (M2702A), FM30 (M2703A), FM40 (M2704A) and FM50 (M2705A); Avalon Patient Module (M2738A); M2734B; MECG Adapter Cable (M1363A); Remote Event Marker (989803143411); Transducers (866075, 866076, 866077, 867245, 867246, 867247, 867248, 867249, M2735A, M2736A, M2736AA)

Specification Developer

transducer, pressure, intrauterine - Avalon Basestation (866074); Avalon CL Fetal & Maternal Pod (866488); Avalon Fetal & Maternal Patch; Avalon Fetal/Maternal Monitors FM20 (M2702A), FM30 (M2703A), FM40 (M2704A) and FM50 (M2705A); Avalon Patient Module (M2738A); M2734B; MECG Adapter Cable (M1363A); Remote Event Marker (989803143411); Transducers (866075, 866076, 866077, 867245, 867246, 867247, 867248, 867249, M2735A, M2736A, M2736AA)

Specification Developer

transducer, ultrasonic, obstetric - Avalon Basestation (866074); Avalon CL Fetal & Maternal Pod (866488); Avalon Fetal & Maternal Patch; Avalon Fetal/Maternal Monitors FM20 (M2702A), FM30 (M2703A), FM40 (M2704A) and FM50 (M2705A); Avalon Patient Module (M2738A); M2734B; MECG Adapter Cable (M1363A); Remote Event Marker (989803143411); Transducers (866075, 866076, 866077, 867245, 867246, 867247, 867248, 867249, M2735A, M2736A, M2736AA)

Specification Developer

system, monitoring, perinatal - Avalon Basestation (866074); Avalon CL Fetal & Maternal Pod (866488); Avalon Fetal & Maternal Patch; Avalon Fetal/Maternal Monitors FM20 (M2702A), FM30 (M2703A), FM40 (M2704A) and FM50 (M2705A); Avalon Patient Module (M2738A); M2734B; MECG Adapter Cable (M1363A); Remote Event Marker (989803143411); Transducers (866075, 866076, 866077, 867245, 867246, 867247, 867248, 867249, M2735A, M2736A, M2736AA)

Specification Developer

plethysmograph, photoelectric, pneumatic or hydraulic - Avalon Basestation (866074); Avalon CL Fetal & Maternal Pod (866488); Avalon Fetal & Maternal Patch; Avalon Fetal/Maternal Monitors FM20 (M2702A), FM30 (M2703A), FM40 (M2704A) and FM50 (M2705A); Avalon Patient Module (M2738A); M2734B; MECG Adapter Cable (M1363A); Remote Event Marker (989803143411); Transducers (866075, 866076, 866077, 867245, 867246, 867247, 867248, 867249, M2735A, M2736A, M2736AA)

Specification Developer

system, network and communication, physiological monitors - Avalon Basestation (866074); Avalon CL Fetal & Maternal Pod (866488); Avalon Fetal & Maternal Patch; Avalon Fetal/Maternal Monitors FM20 (M2702A), FM30 (M2703A), FM40 (M2704A) and FM50 (M2705A); Avalon Patient Module (M2738A); M2734B; MECG Adapter Cable (M1363A); Remote Event Marker (989803143411); Transducers (866075, 866076, 866077, 867245, 867246, 867247, 867248, 867249, M2735A, M2736A, M2736AA)

Specification Developer

system, network and communication, physiological monitors - CareEvent

Specification Developer

recorder, magnetic tape, medical - Patient Information Center iX (PIC iX)

Specification Developer

detector and alarm, arrhythmia - Patient Information Center iX (PIC iX)

Specification Developer

monitor, physiological, patient(with arrhythmia detection or alarms) - Patient Information Center iX (PIC iX)

Specification Developer

monitor, st segment with alarm - Patient Information Center iX (PIC iX)

Specification Developer

system, network and communication, physiological monitors - Patient Information Center iX (PIC iX)

Specification Developer

medical device data system - Patient Information Center iX (PIC iX)

Specification Developer

oximeter - 989803202381 MX40 Adapter 5-Lead + Masimo SpO2; 989803202391 MX40 Adapter Masimo SpO2-only; 989803202411 ECG 5L Grabber, AAMI, Masimo SpO2 , Tele; 989803202421 ECG 5L Grabber, IEC, Masimo SpO2 , Tele; 989803204291 MX40 Adapter 6-Lead + Masimo SpO2; MX40

Specification Developer

transmitters and receivers, physiological signal, radiofrequency - 989803202381 MX40 Adapter 5-Lead + Masimo SpO2; 989803202391 MX40 Adapter Masimo SpO2-only; 989803202411 ECG 5L Grabber, AAMI, Masimo SpO2 , Tele; 989803202421 ECG 5L Grabber, IEC, Masimo SpO2 , Tele; 989803204291 MX40 Adapter 6-Lead + Masimo SpO2; MX40

Specification Developer

monitor, cardiac (incl. cardiotachometer & rate alarm) - 989803202381 MX40 Adapter 5-Lead + Masimo SpO2; 989803202391 MX40 Adapter Masimo SpO2-only; 989803202411 ECG 5L Grabber, AAMI, Masimo SpO2 , Tele; 989803202421 ECG 5L Grabber, IEC, Masimo SpO2 , Tele; 989803204291 MX40 Adapter 6-Lead + Masimo SpO2; MX40

Specification Developer

adaptor, lead switching, electrocardiograph - 989803202381 MX40 Adapter 5-Lead + Masimo SpO2; 989803202391 MX40 Adapter Masimo SpO2-only; 989803202411 ECG 5L Grabber, AAMI, Masimo SpO2 , Tele; 989803202421 ECG 5L Grabber, IEC, Masimo SpO2 , Tele; 989803204291 MX40 Adapter 6-Lead + Masimo SpO2; MX40

Specification Developer

cable, transducer and electrode, patient, (including connector) - 989803202381 MX40 Adapter 5-Lead + Masimo SpO2; 989803202391 MX40 Adapter Masimo SpO2-only; 989803202411 ECG 5L Grabber, AAMI, Masimo SpO2 , Tele; 989803202421 ECG 5L Grabber, IEC, Masimo SpO2 , Tele; 989803204291 MX40 Adapter 6-Lead + Masimo SpO2; MX40

Specification Developer

detector and alarm, arrhythmia - 989803202381 MX40 Adapter 5-Lead + Masimo SpO2; 989803202391 MX40 Adapter Masimo SpO2-only; 989803202411 ECG 5L Grabber, AAMI, Masimo SpO2 , Tele; 989803202421 ECG 5L Grabber, IEC, Masimo SpO2 , Tele; 989803204291 MX40 Adapter 6-Lead + Masimo SpO2; MX40

Specification Developer

monitor, physiological, patient(with arrhythmia detection or alarms) - 989803202381 MX40 Adapter 5-Lead + Masimo SpO2; 989803202391 MX40 Adapter Masimo SpO2-only; 989803202411 ECG 5L Grabber, AAMI, Masimo SpO2 , Tele; 989803202421 ECG 5L Grabber, IEC, Masimo SpO2 , Tele; 989803204291 MX40 Adapter 6-Lead + Masimo SpO2; MX40

Specification Developer

monitor, st segment with alarm - 989803202381 MX40 Adapter 5-Lead + Masimo SpO2; 989803202391 MX40 Adapter Masimo SpO2-only; 989803202411 ECG 5L Grabber, AAMI, Masimo SpO2 , Tele; 989803202421 ECG 5L Grabber, IEC, Masimo SpO2 , Tele; 989803204291 MX40 Adapter 6-Lead + Masimo SpO2; MX40

Specification Developer

system, network and communication, physiological monitors - 989803202381 MX40 Adapter 5-Lead + Masimo SpO2; 989803202391 MX40 Adapter Masimo SpO2-only; 989803202411 ECG 5L Grabber, AAMI, Masimo SpO2 , Tele; 989803202421 ECG 5L Grabber, IEC, Masimo SpO2 , Tele; 989803204291 MX40 Adapter 6-Lead + Masimo SpO2; MX40

Specification Developer

oximeter - 989803205381 Philips Nasal Alar SpO2 Sensor; 989803205391 Philips Nasal Alar SpO2 Sensor; 989803205401 Philips Nasal Alar SpO2 Sensor

Specification Developer

transmitters and receivers, physiological signal, radiofrequency - Philips Biosensor BX100

Complaint File Establishment

analyzer, gas, carbon-dioxide, gaseous-phase - 989803204301 Microstream™ Advance Adult-Pediatric Intubated CO2 Filter Line; 989803204311 Microstream™ Advance Neonatal-Infant Intubated CO2 Filter Line; 989803204321 Microstream™ Advance Adult-Pediatric Intubated CO2 Filter Line; 989803204331 Microstream™ Advance Adult-Pediatric CO2 Intubated Filter Line; 989803204341 Microstream™ Advance Neonatal-Infant Intubated CO2 Filter Line; 989803204511 Microstream™ Advance Adult-Pediatric Intubated CO2 Filter Line; 989803204521 Microstream™ Advance Adult-Pediatric Intubated CO2 Filter Line; 989803204531 Microstream™ Advance Neonatal-Infant Intubated CO2 Filter Line

Complaint File Establishment

analyzer, gas, carbon-dioxide, gaseous-phase - 989803204351 Microstream™ Advance Pediatric Oral-Nasal CO2 Filter Line; 989803204361 Microstream™ Advance Adult Oral-Nasal CO2 Filter Line; 989803204371 Microstream™ Advance Adult Oral-Nasal CO2 Filter Line; 989803204381 Microstream™ Advance Adult Oral-Nasal CO2 Filter Line; 989803204391 Microstream™ Advance Adult Oral-Nasal CO2 Filter Line; 989803204401 Microstream™ Advance Pediatric Oral-Nasal CO2 Filter Line; 989803204411 Microstream™ Advance Pediatric Oral-Nasal CO2 Filter Line; 989803204421 Microstream™ Advance Neonatal-Infant Nasal CO2 Filter Line; 989803204431 Microstream™ Advance Neonatal-Infant Nasal CO2 Filter Line; 989803204441 Microstream™ Advance Neonatal-Infant Nasal CO2 Filter Line; 989803204481 Microstream™ Advance Adult Nasal CO2 Filter Line; 989803204491 Microstream™ Advance Adult Nasal CO2 Filter Line; 989803204501 Microstream™ Advance Pediatric Nasal CO2 Filter Line; 989803204541 Microstream™ Advance Pediatric Oral-Nasal CO2 Filter Line; 989803204551 Microstream™ Advance Adult Oral-Nasal CO2 Filter Line; 989803204561 Microstream™ Advance Pediatric Oral-Nasal CO2 Filter Line; 989803204571 Microstream™ Advance Adult Oral-Nasal CO2 Filter Line; 989803204581 Microstream™ Advance Adult Nasal CO2 Filter Line; 989803204591 Microstream™ Advance Pediatric Nasal CO2 Filter Line; 989803204601 Microstream™ Advance Pediatric Nasal CO2 Filter Line; 989803204611 Microstream™ Advance Adult Nasal CO2 Filter Line; 989803204621 Microstream™ Advance Adult Nasal CO2 Filter Line; 989803204631 Microstream™ Advance Neonatal-Infant Nasal CO2 Filter Line

Complaint File Establishment

analyzer, gas, carbon-dioxide, gaseous-phase - 989803178031 Microstream® EtCO2 Consumables Smart CapnoLine® Guard; 989803178041 Microstream® EtCO2 Consumables Smart CapnoLine® Guard O2; 989803178051 Microstream® EtCO2 Consumables Smart CapnoLine® Guard O2 Long; 989803182991 Microstream® EtCO2 Consumables Smart CapnoLine® Guard O2; 989803183001 Microstream® EtCO2 Consumables Smart CapnoLine® Guard O2 Long; 989803204451 Microstream™ Advance Adult-Intermediate Bite Block CO2 Filter Line; 989803204461 Microstream™ Advance Adult-Intermediate Bite Block CO2 Filter Line; 989803204471 Microstream™ Advance Adult-Intermediate Bite Block CO2 Filter Line

Complaint File Establishment

electrode, circular (spiral), scalp and applicator - 989803137631 Fetal Spiral Electrode

Complaint File Establishment

uterine electromyographic monitor - 989803196341 Avalon CL Fetal & Maternal Patch

Repackager/Relabeler

electrode, electrocardiograph - 2-CH Patch; 40494E, Limb Clamp Electrode; BTP-1000P (Patch); ePatch ECG Electrode; ePatch electrode; MCOT Patch; Neonatal Quadtrode MRI ECG Electrode Pad - 989803179051; Patch; Patch ECG Electrode; Patch electrode; Quadtrode CV MRI ECG Electrode Pad - 989803179041; QUADTRODE MRI ECG PAD,25/BOX - 989803179031; Universal Patch

Specification Developer

electrocardiograph - PageWriter TC30 Cardiograph, TC30 (860306); PageWriter TC50 Cardiograph, TC50 (860310, 860429, 860466); PageWriter TC70 Cardiograph, TC70 (860315, 860352)

Specification Developer

recorder, paper chart - 40457C Chemical/Thermal Paper; 40477A Chemical/Thermal Paper; 989803138171 Defibrillator Chemical/Thermal Paper; 989803138181 Defibrillator Chemical/Thermal Paper; 989803185271 Thermal Roll Paper, 110 mm Wide; 989803190381 Efficia 50mm Chemical Thermal Paper, No Gridlines; M1710A Chemical/Thermal Paper; M2481A Chemical/Thermal Paper; M2483A Chemical/Thermal Paper; M2485A Chemical/Thermal Paper; M3707A Chemical/Thermal Paper; M3708A Chemical/Thermal Paper; M4816A Thermal Paper; M4817A Thermal Paper

Repackager/Relabeler

electrode, electrocardiograph - 989803156201 Adult Disposable Metallic 3 Leadwire Electrode Set, AAMI; 989803156221 Adult Disposable Radiolucent 3 Leadwire Electrode Set, AAMI; 989803156231 Adult Disposable Radiolucent 3 Leadwire Electrode Set, IEC; 989803156241 Adult Disposable Metallic 5 Leadwire Electrode Set, AAMI; 989803156261 Adult Disposable Radiolucent 5 Leadwire Electrode Set, AAMI; 989803156271 Adult Disp Radiolucent 5 Leadwire Electrode Set, IEC

Repackager/Relabeler

electrode, electrocardiograph - 13951C Neonatal/Pediatric Solid Gel Electrode; 13952D Metallic Preattached Leadwire Electrode, Medium; 13953D Metallic Preattached Leadwire Electrode, Square; 13953E Radiolucent Preattached Leadwire Electrode, Square; 13955C Neonatal/Pediatric Snap Electrode, Square

Repackager/Relabeler

electrode, electrocardiograph - 989803192551 Clear Tape Wet Gel ECG Electrode; M4612A Solid Gel Foam Electrode; M4613A Solid Gel Foam Electrode

Repackager/Relabeler

electrode, electrocardiograph - 989803148821 Radiolucent Foam Electrode

Repackager/Relabeler

electrode, electrocardiograph - 13943B Solid Gel Tab Electrode, Resting ECG

Repackager/Relabeler

electrode, electrocardiograph - 40493D Foam Wet Gel ECG Electrode; 40493E Foam Wet Gel ECG Electrode

Repackager/Relabeler

electrode, electrocardiograph - M2202A Radiolucent Foam Electrode

Repackager/Relabeler

analyzer, gas, carbon-dioxide, gaseous-phase - 989803178001 Microstream® EtCO2 Consumables CapnoLine® H O2 Infant/ Neonatal; 989803178021 Microstream® EtCO2 Consumables Nasal FilterLine Infant/Neonatal; 989803179101 Microstream® EtCO2 Consumables Nasal Filterline O2 Adult; 989803179111 Microstream® EtCO2 Consumables Nasal Filterline O2 Adult; 989803179121 Microstream® EtCO2 Consumables Filterline O2 Pediatric; 989803183071 Microstream® EtCO2 Consumables CapnoLine® H O2; M4681A Microstream® EtCO2 Consumables CapnoLine® H O2

Complaint File Establishment

analyzer, gas, carbon-dioxide, gaseous-phase - 989803160301 Microstream® EtCO2 Consumables Smart CapnoLine Plus Long

Complaint File Establishment

electrode, electrocardiograph - 989803183081 Mini NeoLead, AAMI metal lead; 989803183101 989803183101; 989803183121 NeoLead, AAMI radio lead; 989803183141 Micro NeoLead, AAMI radio lead

Repackager/Relabeler

analyzer, gas, carbon-dioxide, gaseous-phase - 989803159581 Microstream® EtCO2 VitaLine H Set; 989803160261 Microstream® EtCO2 VitaLine H Set Long; 989803182921 Microstream® EtCO2 FilterLine H Set; 989803182931 Microstream® EtCO2 FilterLine H Set; 989803182941 Microstream® EtCO2 VitaLine H Set

Complaint File Establishment

analyzer, gas, carbon-dioxide, gaseous-phase - 989803160271 Microstream® EtCO2 Consumables Smart CapnoLine® O2 Long; 989803177951 Microstream® EtCO2 Consumables Smart CapnoLine® H O2 Adult; 989803177961 Microstream® EtCO2 Consumables Smart CapnoLine® H 02 Adult Long; 989803177971 Microstream® EtCO2 Consumables Smart CapnoLine® H 02 Pediatric; 989803177981 Microstream® EtCO2 Consumables Smart CapnoLine® H O2 Pediatric Long; 989803182951 Microstream® EtCO2 Consumables Smart CapnoLine® O2 Pediatric; 989803182961 Microstream® EtCO2 Consumables Smart CapnoLine® O2 Adult; 989803182971 Microstream® EtCO2 Consumables Smart CapnoLine® H O2 Adult; 989803182981 Microstream® EtCO2 Consumables Smart CapnoLine® O2 Long,Adult

Complaint File Establishment

analyzer, gas, carbon-dioxide, gaseous-phase - 989803160241 Microstream® EtCO2 Consumables Filterline Set Long; 989803182911Microstream® EtCO2 Consumables Filterline Set; M1920A Microstream® EtCO2 Consumables Filterline Set

Complaint File Establishment

analyzer, gas, carbon-dioxide, gaseous-phase - 989803178011 Microstream® EtCO2 Consumables CapnoLine H Infant/Neonatal Long; M4686A Microstream® EtCO2 Consumables NIV Line; M4687A Microstream® EtCO2 Consumables NIV Line; M4689A Microstream® EtCO2 Consumables CapnoLine H; M4691A Microstream® EtCO2 Consumables CapnoLine H Infant/Neonatal

Complaint File Establishment

detector and alarm, arrhythmia - M1921A Microstream® EtCO2 FilterLine H Set; Veridia Patient Monitoring System

Complaint File Establishment

thermometer, electronic, clinical - 21075A Esophageal/Rectal 12 Fr Temperature Probe; 21076A Esophageal/Rectal 10 Fr Temperature Probe; 21078A Skin Surface Temperature Probe; 989803203561 Esophageal/Rectal Temperature Probe 12 Fr, Reusable, Autoclavable; 989803203571 Esophageal/Rectal Temperature Probe 10 Fr, Reusable, Autoclavable; 989803203581 Skin Temperature Probe, Reusable, Autoclavable

Repackager/Relabeler

monitor, physiological, patient(with arrhythmia detection or alarms) - 21090A Esophageal/Rectal Temperature Probe 12FR; 21091A Skin Temperature Probe; 23001A Temperature Probe; 23001B Temperature Probe; 23002A Reusable Bath Temperature Probe; M1837A Esophageal/Rectal Temperature Probe 9FR

Repackager/Relabeler

catheter, retention type, balloon - 21096A Foley Catheter Temperature Probe 16FR; 21097A Foley Catheter Temperature Probe 18FR; M2255A Foley Catheter Temperature Probe 14FR

Repackager/Relabeler

monitor, breathing frequency - 989803179541 Mobile CL Respiration Pod Attachment; IntelliVue CL Respiration Pod, SW Rev. B.0; IntelliVue GuardianSoftware SW Rev. A.02; IntelliVue Multi-Measurement Module X2, SW Rev. J.07; IntelliVue Patient Monitor MP2, SW Rev. J.07; IntelliVue Patient Monitor MP5, MP5T, MP5SC, SW Rev. J.07

Complaint File Establishment

electrocardiograph - 989803151631, 12-Lead Complete Lead Set (AAMI), Standard Length; 989803151641, 12-Lead Complete Lead Set (IEC), Standard Length; 989803151651, 12-Lead Complete Lead Set (AAMI), Long; 989803151661, 12-Lead Complete Lead Set (IEC), Long; 989803151671, 12-Lead Chest Lead Set (AAMI/IEC), Standard Length; 989803151691, 12-Lead Chest Lead Set (AAMI/IEC), Long; 989803151711, 12-Lead Limb Lead Set (AAMI/IEC), Standard Length; 989803151731, 12-Lead Limb Lead Set (AAMI/IEC), Long; 989803151751, 15/16/18-Lead Upgrade Kit (AAMI), Standard Length; 989803151761, 15/16/18-Lead Upgrade Kit (IEC), Standard Length; 989803151771, 15/16/18-Lead Upgrade Kit (AAMI), Long; 989803151781, 15/16/18-Lead Upgrade Kit (IEC), Long; 989803164281, USB Patient Data Cable, Class B

Specification Developer

monitor, physiological, patient(with arrhythmia detection or alarms) - Suresigns VSV

Complaint File Establishment

analyzer, gas, carbon-dioxide, gaseous-phase - 863283, SureSigns VS4 Vital Sign Monitor; 863379, SureSigns VS4 U.S. Gov NBP. SPO2

Complaint File Establishment

oximeter - 863283, SureSigns VS4 Vital Sign Monitor; 863379, SureSigns VS4 U.S. Gov NBP. SPO2

Complaint File Establishment

cable, transducer and electrode, patient, (including connector) - 863283, SureSigns VS4 Vital Sign Monitor; 863379, SureSigns VS4 U.S. Gov NBP. SPO2

Complaint File Establishment

alarm, blood-pressure - 863283, SureSigns VS4 Vital Sign Monitor; 863379, SureSigns VS4 U.S. Gov NBP. SPO2

Complaint File Establishment

computer, blood-pressure - 863283, SureSigns VS4 Vital Sign Monitor; 863379, SureSigns VS4 U.S. Gov NBP. SPO2

Complaint File Establishment

system, measurement, blood-pressure, non-invasive - 863283, SureSigns VS4 Vital Sign Monitor; 863379, SureSigns VS4 U.S. Gov NBP. SPO2

Complaint File Establishment

thermometer, electronic, clinical - 863283, SureSigns VS4 Vital Sign Monitor; 863379, SureSigns VS4 U.S. Gov NBP. SPO2

Complaint File Establishment

analyzer, gas, carbon-dioxide, gaseous-phase - VM4 Monitor w/NIBP, SpO2, ECG, Ptemp; VM6 Monitor w/NIBP, SpO2, ECG, Continuous temp; VM6 Monitor w/NIBP, SpO2, ECG, IBP, Continuous temp; VM8 Monitor w/NIBP, SpO2, ECG, IBP, Continuous temperature, 10¿ Display; VM8 Monitor w/NIBP, SpO2, ECG, IBP, Continuous temperature, etCO2, 10¿ Display; VM8 SE w/ NIBP, SpO2, ECG, IBP, Continuous temperature, etCO2, 10¿ Display; VM8 SE w/NIBP, SpO2, ECG, IBP, Continuous temperature, 10¿ Display

Complaint File Establishment

oximeter - VM4 Monitor w/NIBP, SpO2, ECG, Ptemp; VM6 Monitor w/NIBP, SpO2, ECG, Continuous temp; VM6 Monitor w/NIBP, SpO2, ECG, IBP, Continuous temp; VM8 Monitor w/NIBP, SpO2, ECG, IBP, Continuous temperature, 10¿ Display; VM8 Monitor w/NIBP, SpO2, ECG, IBP, Continuous temperature, etCO2, 10¿ Display; VM8 SE w/ NIBP, SpO2, ECG, IBP, Continuous temperature, etCO2, 10¿ Display; VM8 SE w/NIBP, SpO2, ECG, IBP, Continuous temperature, 10¿ Display

Complaint File Establishment

monitor, cardiac (incl. cardiotachometer & rate alarm) - VM4 Monitor w/NIBP, SpO2, ECG, Ptemp; VM6 Monitor w/NIBP, SpO2, ECG, Continuous temp; VM6 Monitor w/NIBP, SpO2, ECG, IBP, Continuous temp; VM8 Monitor w/NIBP, SpO2, ECG, IBP, Continuous temperature, 10¿ Display; VM8 Monitor w/NIBP, SpO2, ECG, IBP, Continuous temperature, etCO2, 10¿ Display; VM8 SE w/ NIBP, SpO2, ECG, IBP, Continuous temperature, etCO2, 10¿ Display; VM8 SE w/NIBP, SpO2, ECG, IBP, Continuous temperature, 10¿ Display

Complaint File Establishment

cable, transducer and electrode, patient, (including connector) - VM4 Monitor w/NIBP, SpO2, ECG, Ptemp; VM6 Monitor w/NIBP, SpO2, ECG, Continuous temp; VM6 Monitor w/NIBP, SpO2, ECG, IBP, Continuous temp; VM8 Monitor w/NIBP, SpO2, ECG, IBP, Continuous temperature, 10¿ Display; VM8 Monitor w/NIBP, SpO2, ECG, IBP, Continuous temperature, etCO2, 10¿ Display; VM8 SE w/ NIBP, SpO2, ECG, IBP, Continuous temperature, etCO2, 10¿ Display; VM8 SE w/NIBP, SpO2, ECG, IBP, Continuous temperature, 10¿ Display

Complaint File Establishment

alarm, blood-pressure - VM4 Monitor w/NIBP, SpO2, ECG, Ptemp; VM6 Monitor w/NIBP, SpO2, ECG, Continuous temp; VM6 Monitor w/NIBP, SpO2, ECG, IBP, Continuous temp; VM8 Monitor w/NIBP, SpO2, ECG, IBP, Continuous temperature, 10¿ Display; VM8 Monitor w/NIBP, SpO2, ECG, IBP, Continuous temperature, etCO2, 10¿ Display; VM8 SE w/ NIBP, SpO2, ECG, IBP, Continuous temperature, etCO2, 10¿ Display; VM8 SE w/NIBP, SpO2, ECG, IBP, Continuous temperature, 10¿ Display

Complaint File Establishment

computer, blood-pressure - VM4 Monitor w/NIBP, SpO2, ECG, Ptemp; VM6 Monitor w/NIBP, SpO2, ECG, Continuous temp; VM6 Monitor w/NIBP, SpO2, ECG, IBP, Continuous temp; VM8 Monitor w/NIBP, SpO2, ECG, IBP, Continuous temperature, 10¿ Display; VM8 Monitor w/NIBP, SpO2, ECG, IBP, Continuous temperature, etCO2, 10¿ Display; VM8 SE w/ NIBP, SpO2, ECG, IBP, Continuous temperature, etCO2, 10¿ Display; VM8 SE w/NIBP, SpO2, ECG, IBP, Continuous temperature, 10¿ Display

Complaint File Establishment

system, measurement, blood-pressure, non-invasive - VM4 Monitor w/NIBP, SpO2, ECG, Ptemp; VM6 Monitor w/NIBP, SpO2, ECG, Continuous temp; VM6 Monitor w/NIBP, SpO2, ECG, IBP, Continuous temp; VM8 Monitor w/NIBP, SpO2, ECG, IBP, Continuous temperature, 10¿ Display; VM8 Monitor w/NIBP, SpO2, ECG, IBP, Continuous temperature, etCO2, 10¿ Display; VM8 SE w/ NIBP, SpO2, ECG, IBP, Continuous temperature, etCO2, 10¿ Display; VM8 SE w/NIBP, SpO2, ECG, IBP, Continuous temperature, 10¿ Display

Complaint File Establishment

thermometer, electronic, clinical - VM4 Monitor w/NIBP, SpO2, ECG, Ptemp; VM6 Monitor w/NIBP, SpO2, ECG, Continuous temp; VM6 Monitor w/NIBP, SpO2, ECG, IBP, Continuous temp; VM8 Monitor w/NIBP, SpO2, ECG, IBP, Continuous temperature, 10¿ Display; VM8 Monitor w/NIBP, SpO2, ECG, IBP, Continuous temperature, etCO2, 10¿ Display; VM8 SE w/ NIBP, SpO2, ECG, IBP, Continuous temperature, etCO2, 10¿ Display; VM8 SE w/NIBP, SpO2, ECG, IBP, Continuous temperature, 10¿ Display

Complaint File Establishment

monitor, physiological, patient(with arrhythmia detection or alarms) - VM4 Monitor w/NIBP, SpO2, ECG, Ptemp; VM6 Monitor w/NIBP, SpO2, ECG, Continuous temp; VM6 Monitor w/NIBP, SpO2, ECG, IBP, Continuous temp; VM8 Monitor w/NIBP, SpO2, ECG, IBP, Continuous temperature, 10¿ Display; VM8 Monitor w/NIBP, SpO2, ECG, IBP, Continuous temperature, etCO2, 10¿ Display; VM8 SE w/ NIBP, SpO2, ECG, IBP, Continuous temperature, etCO2, 10¿ Display; VM8 SE w/NIBP, SpO2, ECG, IBP, Continuous temperature, 10¿ Display

Complaint File Establishment

oximeter - Philips SureSigns Vs2+; SureSigns VS2+; SureSigns VSi

Complaint File Establishment

cable, transducer and electrode, patient, (including connector) - Philips SureSigns Vs2+; SureSigns VS2+; SureSigns VSi

Complaint File Establishment

alarm, blood-pressure - Philips SureSigns Vs2+; SureSigns VS2+; SureSigns VSi

Complaint File Establishment

computer, blood-pressure - Philips SureSigns Vs2+; SureSigns VS2+; SureSigns VSi

Complaint File Establishment

computer, diagnostic, pre-programmed, single-function - Philips SureSigns Vs2+; SureSigns VS2+; SureSigns VSi

Complaint File Establishment

system, measurement, blood-pressure, non-invasive - Philips SureSigns Vs2+; SureSigns VS2+; SureSigns VSi

Complaint File Establishment

thermometer, electronic, clinical - Philips SureSigns Vs2+; SureSigns VS2+; SureSigns VSi

Complaint File Establishment

monitor, physiological, patient(with arrhythmia detection or alarms) - Philips SureSigns Central

Complaint File Establishment

monitor, physiological, patient(with arrhythmia detection or alarms) - SureSigns VM4, VM6, VM8 Government Bundle

Complaint File Establishment

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Establishment Registration & Device Listing

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