Identity
- Trade Name
- Lifogen FDA UDI
- Generic Name
- Fixed-regulator oxygen refillable cylinder FDA UDI
- Device Name
- Emergency Oxygen Unit FDA UDI
- Model / Reference
- 0022-230P FDA UDI
- Description
- Emergency Oxygen Unit FDA UDI
Identifiers
- Catalog Number
- 31-01-0600 FDA UDI
- Primary DI / UDI-DI
- 00026072011010 FDA UDI
- 510(k) Number
- K895956 FDA UDI
- FDA Product Code
- CAN FDA UDI
- GMDN Term
- Fixed-regulator oxygen refillable cylinder FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.2700 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
Yes
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
Yes
FDA UDI
Category: Fixed-regulator oxygen refillable cylinder
Lifogen by Allied Medical LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Allied Medical LLC
Sources (1)
- FDA UDI a1209da7-cf45-4e7c-8e67-e8d148d80318 35 fields · synced Jun 8, 2026