Identity
- Trade Name
- LIFE®SoftPac FDA UDI
- Generic Name
- Fixed-regulator oxygen refillable cylinder FDA UDI
- Device Name
- LIFE®SoftPac Emergency Oxygen Unit is lightweight (6 lbs) for easy portability and frequent carrying. A 6&12 LPM (NORM & HIGH), variable-flow regulator provides a 40 minute supply of oxygen at 6LPM. FDA UDI
- Model / Reference
- LIFE-2-612 FDA UDI
- Description
- LIFE®SoftPac Emergency Oxygen Unit is lightweight (6 lbs) for easy portability and frequent carrying. A 6&12 LPM (NORM & HIGH), variable-flow regulator provides a 40 minute supply of oxygen at 6LPM. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B188LIFE26120 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
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 255 Liter FDA UDI
Category: Fixed-regulator oxygen refillable cylinder
LIFE®SoftPac by Mv Life 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
- Mv Life LLC
Sources (1)
- FDA UDI d08aaf1f-fcf6-4d8f-b94a-665ba7bba20b 36 fields · synced May 30, 2026