Identity
- Trade Name
- Puritan Bennett FDA UDI
- Generic Name
- Carbon dioxide sensor/cable FDA UDI
- Device Name
- Capnography Sensor Reusable For 980 Series Ventilator FDA UDI
- Model / Reference
- 10087409 FDA UDI
- Description
- Capnography Sensor Reusable For 980 Series Ventilator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521659100 FDA UDI
- FDA Product Code
- CBK FDA UDI
- GMDN Term
- Carbon dioxide sensor/cable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5895 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Carbon dioxide sensor/cable
Puritan Bennett by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- 1-Slot CO2/O2 Module w/ kit (Neo) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- 1-Slot CO2 Module w/ kit (Adult/Ped) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- AirLife™ — Airlife, Inc. · Class II
- RM Module(package/no accessory) — Shenzhen Mindray Bio-Medical Electronics Co. · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Covidien LP
Sources (1)
- FDA UDI a04b68d4-3040-4e10-987c-b542569ce1b6 35 fields · synced May 30, 2026