Identity
- Trade Name
- AirLife™ FDA UDI
- Generic Name
- Non-rebreathing valve, reusable FDA UDI
- Device Name
- AirLife™ Pediatric Manual Resuscitator; 40"(1.0m) Oxygen Resevoir Tubing, PEEP Valve, Pediatric Mask, Pressure Limiting Valve with Lock FDA UDI
- Model / Reference
- 2K8037 FDA UDI
- Description
- AirLife™ Pediatric Manual Resuscitator; 40"(1.0m) Oxygen Resevoir Tubing, PEEP Valve, Pediatric Mask, Pressure Limiting Valve with Lock FDA UDI
Identifiers
- Catalog Number
- 2K8037 FDA UDI
- Primary DI / UDI-DI
- 10190752114432 FDA UDI
- FDA Product Code
- OFP FDA UDI
- GMDN Term
- Non-rebreathing valve, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5240 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
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 1000.00 Milliliter FDA UDIWeight — .40 Kilogram FDA UDI
Category: Non-rebreathing valve, reusable
AirLife™ by Airlife, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-rebreathing valve, reusable.
- AincA — Anesthesia Associates, Inc. · Class II
- RESMED — RESMED PTY LTD · Class II
- BE 30-115-B Exhalation Valve — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class II
- KIT-BAG TEE/SCAV SWIVEL ASSY — Parker Hannifin Corp. · Class I
- BE 30-115-BL Low Resistance Exhalation Valve — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class II
- BE 131 One-Way Valve — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class II
- BE 117 Non-Rebreathing Tee Valve — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class II
- Disposable Exp. Valve Carina — Drägerwerk AG & Co. KGaA · 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
- Airlife, Inc.
Sources (1)
- FDA UDI 15132b8e-a737-492c-a006-64f3aaef1680 37 fields · synced May 30, 2026