Identity
- Trade Name
- LIFE®Regulator FDA UDI
- Generic Name
- Non-fixed medical gas cylinder regulator FDA UDI
- Device Name
- Oxygen regulator providing variable 6 & 12 LPM flow-rates. For use with LIFE® Emergency Oxygen Units. FDA UDI
- Model / Reference
- LIFE-612 Regulator FDA UDI
- Description
- Oxygen regulator providing variable 6 & 12 LPM flow-rates. For use with LIFE® Emergency Oxygen Units. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B188LIFE612REG0 FDA UDI
- FDA Product Code
- CAN FDA UDI
- GMDN Term
- Non-fixed medical gas cylinder regulator 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
No
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
Category: Non-fixed medical gas cylinder regulator
LIFE®Regulator 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 a521a5a6-2ab0-4ff5-9d9e-2e8366a3af3e 34 fields · synced May 30, 2026