Identity
- Trade Name
- LIFEPAK CR2 FDA UDI
- Generic Name
- Non-rechargeable public semi-automated external defibrillator FDA UDI
- Device Name
- CR2BAAAABFHBBBCDBCDBAAAALPCR2 CONFIGURED UNIT FDA UDI
- Model / Reference
- 99512 FDA UDI
- Description
- CR2BAAAABFHBBBCDBCDBAAAALPCR2 CONFIGURED UNIT FDA UDI
Identifiers
- Catalog Number
- 99512-001261 FDA UDI
- Primary DI / UDI-DI
- 00883873824139 FDA UDI
- PMA Number
- P170018 FDA UDI
- FDA Product Code
- MKJ FDA UDI
- GMDN Term
- Non-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: Non-rechargeable public semi-automated external defibrillator
The LIFEPAK CR2 is a portable, non-rechargeable public semi-automated external defibrillator (PSED) designed to automatically detect cardiac arrhythmias in sudden cardiac arrest patients. This device consists of two skin-adhesive, cartridge-type disposable electrodes containing non-rechargeable batteries that provide the shock energy, and an electrode-regulating external pulse generator. It is intended for laypersons to operate and provides CPR feedback.
Similar devices
Also classified as Non-rechargeable public semi-automated external defibrillator.
- Powerheart® G5 TSO Kit, Semi, US EN/LA ESP — Zoll Medical Corporation · Class III
- AED PLUS — Zoll Medical Corporation · Class III
- Powerheart® AED G3 Plus Semi Automatic — Zoll Medical Corporation · Class III
- AED PLUS — Zoll Medical Corporation · Class III
- Powerheart® AED G3 Pro AED — Zoll Medical Corporation · Class III
- samaritan PAD — HEARTSINE TECHNOLOGIES LTD · Class III
- Powerheart® G3 Pro Battery Charger — Cardiac Science Corporation · Class III
- DDU-100 Lifeline AED with RX form and cabinet — DEFIBTECH, L.L.C. · Class III
Cleared under the same submission
P170018 also covers:
- LIFEPAK — PHYSIO-CONTROL, Inc.
- LIFEPAK — PHYSIO-CONTROL, Inc.
- LIFEPAK CR2 — PHYSIO-CONTROL, Inc.
- LIFEPAK CR2 — PHYSIO-CONTROL, Inc.
- LIFEPAK CR2 — PHYSIO-CONTROL, Inc.
- LIFEPAK CR2 — PHYSIO-CONTROL, Inc.
- LIFEPAK CR2 — PHYSIO-CONTROL, Inc.
- LIFEPAK CR2 — PHYSIO-CONTROL, Inc.
- LIFEPAK CR2 — PHYSIO-CONTROL, Inc.
- QUIK-STEP — 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 cfc8e789-3a09-425a-ab35-0384054a3ca8 37 fields · synced Jul 8, 2026