Identity
- Trade Name
- Puritan Bennett FDA UDI
- Generic Name
- Carbon dioxide cuvette, single-use FDA UDI
- Device Name
- Neonatal Flow and CO2 Sensor Disposable;For 980 Series Ventilator FDA UDI
- Model / Reference
- 10005002 FDA UDI
- Description
- Neonatal Flow and CO2 Sensor Disposable;For 980 Series Ventilator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20884521139852 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Carbon dioxide cuvette, single-use
Puritan Bennett by Covidien LP — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Carbon dioxide cuvette, single-use.
- Respiratory Mechanics Combined Flow/CO2 Sensor – Pediatric — Draeger Medical Systems, Inc. · Class II
- Airway Adapters — Respironics Novametrix, LLC · Class I
- Newport Medical — Newport Medical Instruments · Class II
- Disposable CO2 Cuvette paed. — Drägerwerk AG & Co. KGaA · Class II
- Respiratory Mechanics Sensor – Neonatal — Draeger Medical Systems, Inc. · Class II
- Airway Adapters — Respironics Novametrix, LLC · Class I
- Respiratory Mechanics Combined Flow/CO2 Sensor – Adult/pediatric — Draeger Medical Systems, Inc. · Class II
- Respiratory Mechanics Combined Flow/CO2 Sensor – Neonatal — Draeger Medical Systems, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Covidien LP
Sources (1)
- FDA UDI d5cd508f-c97d-40bb-9ae7-5ab97f6bbbb1 35 fields · synced May 31, 2026