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LIFEPAK CR Plus and LIFEPAK Express defibrillators

FDA UDI

Class III (US FDA UDI)

by PHYSIO-CONTROL, Inc.

Identity

Trade Name
LIFEPAK CR Plus and LIFEPAK Express defibrillators FDA UDI
Generic Name
Rechargeable public semi-automated external defibrillator FDA UDI
Device Name
PACKAGE, LP EXPRESS, SEMI, CHECK FOR BREATHING FDA UDI
Model / Reference
80427 FDA UDI
Description
PACKAGE, LP EXPRESS, SEMI, CHECK FOR BREATHING FDA UDI

Identifiers

Catalog Number
80427-000002 FDA UDI
Primary DI / UDI-DI
00883873823743 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

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
MRI Safety
MR Unsafe FDA UDI

Category: Rechargeable public semi-automated external defibrillator

LIFEPAK CR Plus and LIFEPAK Express defibrillators by PHYSIO-CONTROL, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rechargeable public semi-automated external defibrillator.

Cleared under the same submission

P160012 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
PHYSIO-CONTROL, Inc.

Sources (1)

  • FDA UDI 062b374f-48da-47c2-a76f-c61ab13eb54e 37 fields · synced Jun 9, 2026