Identity
- Trade Name
- O2-Life™ FDA UDI
- Generic Name
- Non-rebreathing oxygen face mask FDA UDI
- Device Name
- 02-Life Non - Rebreather Mask High Concentration w/7' (2.1m) Tubing 750ml ReserviorvBag Standard Connector ADULT FDA UDI
- Model / Reference
- RTG-04004 FDA UDI
- Description
- 02-Life Non - Rebreather Mask High Concentration w/7' (2.1m) Tubing 750ml ReserviorvBag Standard Connector ADULT FDA UDI
Identifiers
- Catalog Number
- RTG-04004 FDA UDI
- Primary DI / UDI-DI
- 00850108006608 FDA UDI
- FDA Product Code
- KGB FDA UDI
- GMDN Term
- Non-rebreathing oxygen face mask FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5570 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Non-rebreathing oxygen face mask
O2-Life™ by Cutting Edge Hc Brands Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Non-rebreathing oxygen face mask.
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- BF — Allied Medical LLC · Class I
- Procedural Oxygen Mask — Stryker Corp. · Class II
- Curaplex — BOUND TREE MEDICAL, LLC · Class I
- Ventlab — Ventlab Corp. · Class I
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
- Cutting Edge Hc Brands Llc
Sources (1)
- FDA UDI 97bf3347-0e7e-409e-86f0-84cd4654270e 36 fields · synced Jun 8, 2026