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Respiratory Mechanics Flow Sensor – Adult/Pediatric
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Respiratory Mechanics Flow Sensor – Adult/Pediatric FDA UDI
- Generic Name
- Carbon dioxide cuvette, single-use FDA UDI
- Model / Reference
- 5957134 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049098007740 FDA UDI
- FDA Product Code
- BXP FDA UDI
- GMDN Term
- Carbon dioxide cuvette, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.2885 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Carbon dioxide cuvette, single-use
Respiratory Mechanics Flow Sensor – Adult/Pediatric by Draeger Medical Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Carbon dioxide cuvette, single-use.
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- Newport — Covidien LP · Class II
- Airway Adapters — Respironics Novametrix, LLC · Class I
- Disposable CO2 cuvette, adult — Drägerwerk AG & Co. KGaA · Class II
- Vela — VYAIRE MEDICAL, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Draeger Medical Systems, Inc.
Sources (1)
- FDA UDI cfc58d06-c895-4c93-8c3f-1feb54a63840 33 fields · synced Jun 9, 2026