Identity
- Trade Name
- AirLife™ FDA UDI
- Generic Name
- Carbon dioxide sensor/cable FDA UDI
- Device Name
- Large AirLifeSeeBreath CO2Detector FDA UDI
- Model / Reference
- 2K8085 FDA UDI
- Description
- Large AirLifeSeeBreath CO2Detector FDA UDI
Identifiers
- Catalog Number
- 2K8085 FDA UDI
- Primary DI / UDI-DI
- 10190752156036 FDA UDI
- FDA Product Code
- CCK FDA UDI
- GMDN Term
- Carbon dioxide sensor/cable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1400 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Carbon dioxide sensor/cable
AirLife™ by Airlife, Inc. — 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
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- RM Module(package/no accessory) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- 1-Slot CO2 Module — 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
- Airlife, Inc.
Sources (1)
- FDA UDI f459911e-5fbe-462d-b4c0-179b6ae0338b 36 fields · synced Jun 8, 2026