Identity
- Trade Name
- LIFE®CPR Mask FDA UDI
- Generic Name
- Cardiopulmonary resuscitation mask, single-use FDA UDI
- Device Name
- LIFE®CPR Mask with one-way valve in nylon zip bag. FDA UDI
- Model / Reference
- LIFE-100-B FDA UDI
- Description
- LIFE®CPR Mask with one-way valve in nylon zip bag. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B188LIFE100B0 FDA UDI
- 510(k) Number
- K010191 FDA UDI
- FDA Product Code
- CBP FDA UDI
- GMDN Term
- Cardiopulmonary resuscitation mask, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5870 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardiopulmonary resuscitation mask, single-use
LIFE®CPR Mask by Mv Life LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cardiopulmonary resuscitation mask, single-use.
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Cleared under the same submission
K010191 also covers:
- LSP — Allied Medical LLC
- LSP — Allied Medical LLC
- LSP — Allied Medical LLC
- LSP — Allied Medical LLC
- LSP — Allied Medical LLC
- LSP — Allied Medical LLC
- LSP — Allied Medical LLC
- LSP — Allied Medical LLC
- LSP — Allied Medical LLC
- LSP — Allied Medical LLC
- LSP — Allied Medical LLC
- Facemask with O2, headstrap and one way valve — B.L.S. Systems Limited
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mv Life LLC
Sources (1)
- FDA UDI 6042d19d-5f32-441a-97f0-d56cfe1164db 35 fields · synced Jun 8, 2026