Identity
- Trade Name
- LIFEPAK 15 Monitor/Defibrillator FDA UDI
- Generic Name
- Physiologic-monitoring defibrillation system FDA UDI
- Device Name
- USED LP15,EN,SPO2COMET,3L/12L,EX,NIBP,CO2,IP,TR,VR,V4 FDA UDI
- Model / Reference
- 99577 FDA UDI
- Description
- USED LP15,EN,SPO2COMET,3L/12L,EX,NIBP,CO2,IP,TR,VR,V4 FDA UDI
Identifiers
- Catalog Number
- 99577-001937U FDA UDI
- Primary DI / UDI-DI
- 07613327650839 FDA UDI
- PMA Number
- P160026 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
- 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
Category: Physiologic-monitoring defibrillation system
LIFEPAK 15 Monitor/Defibrillator by PHYSIO-CONTROL, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Physiologic-monitoring defibrillation system.
- R SERIES — Zoll Medical Corporation · Class II
- X SERIES — Zoll Medical Corporation · Class II
- X SERIES — Zoll Medical Corporation · Class II
- M SERIES BIPHASIC — Zoll Medical Corporation · Class II
- M SERIES BIPHASIC — Zoll Medical Corporation · Class II
- R SERIES — Zoll Medical Corporation · Class II
- X SERIES — Zoll Medical Corporation · Class II
- X SERIES — Zoll Medical Corporation · Class II
Cleared under the same submission
P160026 also covers:
- ASSY, CABLE, THERAPY, LP35 — PHYSIO-CONTROL, Inc.
- LIFEPAK 1000 defibrillator — PHYSIO-CONTROL, Inc.
- LIFEPAK 1000 defibrillator — PHYSIO-CONTROL, Inc.
- LIFEPAK 1000 defibrillator — PHYSIO-CONTROL, Inc.
- LIFEPAK 1000 defibrillator — PHYSIO-CONTROL, Inc.
- LIFEPAK 1000 defibrillator — PHYSIO-CONTROL, Inc.
- LIFEPAK 1000 defibrillator — PHYSIO-CONTROL, Inc.
- LIFEPAK 1000 defibrillator — PHYSIO-CONTROL, Inc.
- LIFEPAK 15 MONITOR/DEFIBRILLATOR — PHYSIO-CONTROL, Inc.
- LIFEPAK 15 monitor/defibrillator — PHYSIO-CONTROL, Inc.
- LIFEPAK 15 monitor/defibrillator — PHYSIO-CONTROL, Inc.
- LIFEPAK 15 monitor/defibrillator — PHYSIO-CONTROL, Inc.
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 132c7242-d44c-49da-a047-1f5c6193accb 36 fields · synced Jun 9, 2026