Identity
- Trade Name
- LISO2,FAA,LITHIUM BATTERY FDA UDI
- Generic Name
- Primary battery FDA UDI
- Device Name
- ASSY-BATTERY,LITHIUM,4CELL,DSIZE,ENG,FAA FDA UDI
- Model / Reference
- 11141 FDA UDI
- Description
- ASSY-BATTERY,LITHIUM,4CELL,DSIZE,ENG,FAA FDA UDI
Identifiers
- Catalog Number
- 11141-000014 FDA UDI
- Primary DI / UDI-DI
- 00883873796153 FDA UDI
- 510(k) Number
- K052057 FDA UDI
- FDA Product Code
- MKJ FDA UDI
- GMDN Term
- Primary battery FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 870.5310 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Primary battery
Liso2, Faa, Lithium Battery by PHYSIO-CONTROL, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K052057 also covers:
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 III | Pending data |
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Manufacturer
- Manufacturer
- PHYSIO-CONTROL, Inc.
Sources (1)
- FDA UDI 8ad4e329-faa4-4780-885d-11e48c584814 37 fields · synced Jun 9, 2026