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LIFEPAK® 12 defibrillator/monitor
FDA UDIFDA 510(k)Class III (US FDA UDI)
510(k) K102972
Identity
- Trade Name
- LIFEPAK® 12 defibrillator/monitor FDA UDI
- Generic Name
- Physiologic-monitoring defibrillation system FDA UDI
- Device Name
- LP12AABCBBBABABBAABAAAAALP12 MONITOR-DEFIB FDA UDI
- Model / Reference
- 99400 FDA UDI
- Description
- LP12AABCBBBABABBAABAAAAALP12 MONITOR-DEFIB FDA UDI
Identifiers
- Catalog Number
- 99400-002501 FDA UDI
- Primary DI / UDI-DI
- 00885074269214 FDA UDI
- FDA Product Code
- MKJ FDA UDI
- GMDN Term
- Physiologic-monitoring defibrillation system FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 870.5310 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
LIFEPAK® 12 defibrillator/monitor by PHYSIO-CONTROL, Inc. — Class III — FDA_510K — listed in FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K102972 | Class III | Active |
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Manufacturer
- Manufacturer
- PHYSIO-CONTROL, Inc.
Sources (2)
- FDA UDI 3c75c9bb-1835-40d2-b9c7-f46e72410889 60 fields · synced Jun 18, 2026
- FDA 510(k) K102972 1 fields · synced May 29, 2026