|
Section No. |
Regulation Name Product Code-Device Name |
Class |
|
868.1075 |
Argon gas analyzer. |
|
|
|
JEG - Analyzer, Gas, Argon, Gaseous-Phase |
II |
|
868.1150 |
Indwelling blood carbon dioxide partial pressure (P2CO2) analyzer. |
|
|
|
CCC - Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling |
II |
|
868.1170 |
Indwelling blood hydrogen ion concentration (pH) analyzer. |
|
|
|
CBZ - Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling |
II |
|
868.1200 |
Indwelling blood oxygen partial pressure (PO2) analyzer. |
|
|
|
CCE - Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling |
II |
|
868.1400 |
Carbon dioxide gas analyzer. |
|
|
|
CCK - Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase |
II |
|
868.1430 |
Carbon monoxide gas analyzer. |
|
|
|
CCJ - Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase |
II |
|
868.1500 |
Enflurane gas analyzer. |
|
|
|
CBQ - Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) |
II |
|
|
NHO - Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) |
II |
|
|
NHP - Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) |
II |
|
|
NHQ - Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) |
II |
|
868.1620 |
Halothane gas analyzer. |
|
|
|
CBS - Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) |
II |
|
868.1640 |
Helium gas analyzer. |
|
|
|
BSE - Analyzer, Gas, Helium, Gaseous-Phase |
II |
|
868.1670 |
Neon gas analyzer. |
|
|
|
JEF - Analyzer, Gas, Neon, Gaseous-Phase |
II |
|
868.1690 |
Nitrogen gas analyzer. |
|
|
|
CCI - Analyzer, Gas, Nitrogen, Gaseous-Phase |
II |
|
868.1700 |
Nitrous oxide gas analyzer. |
|
|
|
CBR - Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) |
II |
|
868.1720 |
Oxygen gas analyzer. |
|
|
|
CCL - Analyzer, Gas, Oxygen, Gaseous-Phase |
II |
|
868.1730 |
Oxygen uptake computer. |
|
|
|
BZL - Computer, Oxygen-Uptake |
II |
|
868.1750 |
Pressure plethysmograph. |
|
|
|
CCM - Plethysmograph, Pressure |
II |
|
868.1760 |
Volume plethysmograph. |
|
|
|
JEH - Plethysmograph, Volume |
II |
|
868.1780 |
Inspiratory airway pressure meter. |
|
|
|
BXR - Meter, Airway Pressure (Inspiratory Force) |
II |
|
868.1800 |
Rhinoanemometer. |
|
|
|
BXQ - Rhinoanemometer (Measurement Of Nasal Decongestion) |
II |
|
868.1840 |
Diagnostic spirometer. |
|
|
|
BZG - Spirometer, Diagnostic |
II |
|
868.1850 |
Monitoring spirometer. |
|
|
|
BZK - Spirometer, Monitoring (W/Wo Alarm) |
II |
|
868.1860 |
Peak-flow meter for spirometry. |
|
|
|
BZH - Meter, Peak Flow, Spirometry |
II |
|
868.1880 |
Pulmonary-function data calculator. |
|
|
|
BZC - Calculator, Pulmonary Function Data |
II |
|
868.1890 |
Predictive pulmonary-function value calculator. |
|
|
|
BTY - Calculator, Predicted Values, Pulmonary Function |
II |
|
|
PDT - Burn Resuscitation Decision Support Software |
II |
|
868.1900 |
Diagnostic pulmonary-function interpretation calculator. |
|
|
|
BZM - Calculator, Pulmonary Function Interpretor (Diagnostic) |
II |
|
|
PHZ - Abnormal Breath Sound Device |
II |
|
868.1920 |
Esophageal stethoscope with electrical conductors. |
|
|
|
BZT - Stethoscope, Esophageal, With Electrical Conductors |
II |
|
868.2025 |
Ultrasonic air embolism monitor. |
|
|
|
CBA - Monitor, Air Embolism, Ultrasonic |
II |
|
868.2375 |
Breathing frequency monitor. |
|
|
|
BZQ - Monitor, Breathing Frequency |
II |
|
|
MNR - Ventilatory Effort Recorder |
II |
|
|
PRK - Device Indicating An Exhalation Event |
II |
|
868.2385 |
Nitrogen dioxide analyzer. |
|
|
|
MRQ - Analyzer, Nitrogen Dioxide |
II |
|
868.2600 |
Airway pressure monitor. |
|
|
|
CAP - Monitor, Airway Pressure (Includes Gauge And/Or Alarm) |
II |
|
868.2775 |
Electrical peripheral nerve stimulator. |
|
|
|
BXM - Stimulator, Nerve, Ac-Powered |
II |
|
|
BXN - Stimulator, Nerve, Battery-Powered |
II |
|
|
KOI - Stimulator, Nerve, Peripheral, Electric |
II |
|
868.5090 |
Emergency airway needle. |
|
|
|
BWC - Needle, Emergency Airway |
II |
|
868.5095 |
Retrograde intubation device. |
|
|
|
QCX - Retrograde Intubation Set |
II |
|
868.5120 |
Anesthesia conduction catheter. |
|
|
|
BSO - Catheter, Conduction, Anesthetic |
II |
|
|
MAJ - Catheter, Percutaneous, Intraspinal, Short Term |
II |
|
868.5130 |
Anesthesia conduction filter. |
|
|
|
BSN - Filter, Conduction, Anesthetic |
II |
|
868.5140 |
Anesthesia conduction kit. |
|
|
|
CAZ - Anesthesia Conduction Kit |
II |
|
868.5150 |
Anesthesia conduction needle. |
|
|
|
BSP - Needle, Conduction, Anesthetic (W/Wo Introducer) |
II |
|
|
MIA - Needle, Spinal, Short Term |
II |
|
|
NMR - Needle, Spinal, Short Term, Reprocessed |
II |
|
|
NNH - Needle, Conduction, Anesthesia, Reprocessed |
II |
|
868.5170 |
Laryngotracheal topical anesthesia applicator. |
|
|
|
CCT - Applicator (Laryngo-Tracheal), Topical Anesthesia |
II |
|
868.5260 |
Breathing circuit bacterial filter. |
|
|
|
CAH - Filter, Bacterial, Breathing-Circuit |
II |
|
868.5270 |
Breathing system heater. |
|
|
|
BZE - Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer |
II |
|
868.5330 |
Breathing gas mixer. |
|
|
|
BZR - Mixer, Breathing Gases, Anesthesia Inhalation |
II |
|
868.5430 |
Gas-scavenging apparatus. |
|
|
|
CBN - Apparatus, Gas-Scavenging |
II |
|
868.5440 |
Portable oxygen generator. |
|
|
|
CAW - Generator, Oxygen, Portable |
II |
|
868.5450 |
Respiratory gas humidifier. |
|
|
|
OBN - Humidifier, Respiratory, Mask (Direct Patient Interface) |
II |
|
868.5470 |
Hyperbaric chamber. |
|
|
|
CBF - Chamber, Hyperbaric |
II |
|
868.5655 |
Portable liquid oxygen unit. |
|
|
|
BYJ - Unit, Liquid-Oxygen, Portable |
II |
|
868.5665 |
Powered percussor. |
|
|
|
BYI - Percussor, Powered-Electric |
II |
|
868.5690 |
Incentive spirometer. |
|
|
|
BWF - Spirometer, Therapeutic (Incentive) |
II |
|
868.5730 |
Tracheal tube. |
|
|
|
LNZ - Changer, Tube, Endotracheal |
II |
|
868.5750 |
Inflatable tracheal tube cuff. |
|
|
|
BSK - Cuff, Tracheal Tube, Inflatable |
II |
|
868.5800 |
Tracheostomy tube and tube cuff. |
|
|
|
BTO - Tube, Tracheostomy (W/Wo Connector) |
II |
|
|
JOH - Tube Tracheostomy And Tube Cuff |
II |
|
868.5870 |
Nonrebreathing valve. |
|
|
|
CBP - Valve, Non-Rebreathing |
II |
|
868.5880 |
Anesthetic vaporizer. |
|
|
|
CAD - Vaporizer, Anesthesia, Non-Heated |
II |
|
868.5895 |
Continuous ventilator. |
|
|
|
MOD - Accessory To Continuous Ventilator (Respirator) |
II |
|
868.5905 |
Noncontinuous ventilator (IPPB). |
|
|
|
NFB - Conserver, Oxygen |
II |
|
868.5915 |
Manual emergency ventilator. |
|
|
|
BTM - Ventilator, Emergency, Manual (Resuscitator) |
II |
|