LIFEPAK CR Plus and LIFEPAK Express defibrillators
FDA UDIClass III (US FDA UDI)
Identity
- Trade Name
- LIFEPAK CR Plus and LIFEPAK Express defibrillators FDA UDI
- Generic Name
- Rechargeable public semi-automated external defibrillator FDA UDI
- Device Name
- ASSY-LPCR+,SEMI,CIRCULATION PROMPT,200-300-360 FDA UDI
- Model / Reference
- 99403 FDA UDI
- Description
- ASSY-LPCR+,SEMI,CIRCULATION PROMPT,200-300-360 FDA UDI
Identifiers
- Catalog Number
- 99403-000110 FDA UDI
- Primary DI / UDI-DI
- 00883873820292 FDA UDI
- PMA Number
- P160012 FDA UDI
- FDA Product Code
- MKJ FDA UDI
- GMDN Term
- Rechargeable public semi-automated external defibrillator 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
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
No
Category: Rechargeable public semi-automated external defibrillator
This portable electronic device designed to automatically detect cardiac arrhythmias and deliver defibrillation shocks in sudden cardiac arrest situations, with an external pulse generator and skin-adhesive electrodes. Rechargeable, public semi-automated, and intended for layperson operation.
Similar devices
Also classified as Rechargeable public semi-automated external defibrillator.
- LIFEPAK® CR Plus and LIFEPAK Express defibrillators — PHYSIO-CONTROL, Inc. · Class III
- LIFEPAK CR Plus and LIFEPAK Express defibrillators — PHYSIO-CONTROL, Inc.
- LIFEPAK CR Plus and LIFEPAK Express defibrillators — PHYSIO-CONTROL, Inc.
- LIFEPAK CR Plus and LIFEPAK Express defibrillators — PHYSIO-CONTROL, Inc.
- LIFEPAK CR Plus and LIFEPAK Express defibrillators — PHYSIO-CONTROL, Inc. · Class III
- LIFEPAK CR Plus and LIFEPAK Express defibrillators — PHYSIO-CONTROL, Inc. · Class III
- LIFEPAK CR Plus and LIFEPAK Express defibrillators — PHYSIO-CONTROL, Inc. · Class III
- LIFEPAK CR Plus and LIFEPAK Express defibrillators — PHYSIO-CONTROL, Inc.
Cleared under the same submission
P160012 also covers:
- CHARGE-PAK Charging Unit & 2 QUIK-PAK Electrodes — PHYSIO-CONTROL, Inc.
- ELECTRODE ASSY-QUIK-COMBO — PHYSIO-CONTROL, Inc.
- LIFEPAK CR Plus and LIFEPAK Express defibrillators — PHYSIO-CONTROL, Inc.
- LIFEPAK CR Plus and LIFEPAK Express defibrillators — PHYSIO-CONTROL, Inc.
- LIFEPAK CR Plus and LIFEPAK Express defibrillators — PHYSIO-CONTROL, Inc.
- LIFEPAK CR Plus and LIFEPAK Express defibrillators — PHYSIO-CONTROL, Inc.
- LIFEPAK CR Plus and LIFEPAK Express defibrillators — PHYSIO-CONTROL, Inc.
- LIFEPAK CR Plus and LIFEPAK Express defibrillators — PHYSIO-CONTROL, Inc.
- LIFEPAK CR Plus and LIFEPAK Express defibrillators — PHYSIO-CONTROL, Inc.
- LIFEPAK CR Plus and LIFEPAK Express defibrillators — PHYSIO-CONTROL, Inc.
- LIFEPAK CR Plus and LIFEPAK Express defibrillators — PHYSIO-CONTROL, Inc.
- LIFEPAK CR Plus and LIFEPAK Express defibrillators — PHYSIO-CONTROL, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
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 ace1e4f8-c23c-42b1-8508-e39657f0639e 37 fields · synced Jul 8, 2026