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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: CapnoTrak CO2 Nasal Cannula; CapnoTrak CO2 Oral Nasal Cannula; CapnoTrak CO2 Sampling Extension Line; CapnoTrak CO2/O2 Nasal Cannula; CapnoTrak CO2/O2 Oral Nasal Cannula; CapnoTrak Dehumidification Tubing; CapnoTrak O2 Delivery Extension Line; CapnoTrak Water Filter Assembly; Dehumidification Tubing - 1 ft.; Neonatal and Pediatric CO2 Airway Adapter, Reusable; Neonatal Flow and CO2 Sensor, Disposable; Pediatric and Adult CO2 Airway Adapter, Reusable; Proximal Flow Sensor, Neonatal; SAMPLING LINE MALE LUER-LOK ADAPTER DEH
Classification Name: CANNULA, NASAL, OXYGEN
Product Code: CAT
Device Class: 1
Regulation Number: 868.5340
Medical Specialty: Anesthesiology
Registered Establishment Name: Philips Electronics Ltd
Registered Establishment Number: 3000126629
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Foreign Exporter
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