Identity
- Trade Name
- LIFEPAK CR2 FDA UDI
- Generic Name
- Non-rechargeable public semi-automated external defibrillator FDA UDI
- Device Name
- CR2BBAAADHHBBBCDBCDBAAAALPCR2 CONFIGURED UNIT FDA UDI
- Model / Reference
- 99512 FDA UDI
- Description
- CR2BBAAADHHBBBCDBCDBAAAALPCR2 CONFIGURED UNIT FDA UDI
Identifiers
- Catalog Number
- 99512-001266 FDA UDI
- Primary DI / UDI-DI
- 00883873824085 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
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 semi-automated external defibrillator
Lifepak Cr2 by PHYSIO-CONTROL, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- PHYSIO-CONTROL, Inc.
Sources (1)
- FDA UDI a799527c-f00b-42ca-83b7-65480d23d7bf 37 fields · synced Jun 9, 2026