Identity
- Trade Name
- LIFEPAK CR2 FDA UDI
- Generic Name
- Non-rechargeable public automated external defibrillator FDA UDI
- Device Name
- CR2BAAAABBHBBBCDBCDBAAAALPCR2 CONFIGURED UNIT FDA UDI
- Model / Reference
- 99512 FDA UDI
- Description
- CR2BAAAABBHBBBCDBCDBAAAALPCR2 CONFIGURED UNIT FDA UDI
Identifiers
- Catalog Number
- 99512-001263 FDA UDI
- Primary DI / UDI-DI
- 00883873824115 FDA UDI
- PMA Number
- P170018 FDA UDI
- FDA Product Code
- MKJ FDA UDI
- GMDN Term
- Non-rechargeable public 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Non-rechargeable public automated external defibrillator
Lifepak Cr2 by PHYSIO-CONTROL, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-rechargeable public automated external defibrillator.
- Powerheart® G5 Automatic AED — Zoll Medical Corporation · Class III
- Powerheart G5 Automatic AED — Zoll Medical Corporation · Class III
- Powerheart® AED G3 Automatic AED — Zoll Medical Corporation · Class III
- AED PLUS — Zoll Medical Corporation · Class III
- Lifeline Auto — DEFIBTECH, L.L.C. · Class III
- HeartSine Samaritan PAD 360P — HEARTSINE TECHNOLOGIES LTD · Class III
- Powerheart® AED G3 Plus Automatic AED — Cardiac Science Corporation · Class III
- AED PLUS — Zoll Medical Corporation · 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
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- PHYSIO-CONTROL, Inc.
Sources (1)
- FDA UDI c809880e-3022-497a-859b-4ffdf1c6dd72 37 fields · synced Jun 9, 2026