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LIFEPAK® 500 Automated External Defibrillator

FDA UDI

Class III (US FDA UDI)

by PHYSIO-CONTROL, Inc.

Identity

Trade Name
LIFEPAK® 500 Automated External Defibrillator FDA UDI
Generic Name
Non-rechargeable public semi-automated external defibrillator FDA UDI
Device Name
FINAL ASSY-LP500,ENGLISHVOICE,2 BUTTON OP FDA UDI
Model / Reference
99401 FDA UDI
Description
FINAL ASSY-LP500,ENGLISHVOICE,2 BUTTON OP FDA UDI

Identifiers

Catalog Number
99401-000146 FDA UDI
Primary DI / UDI-DI
00681490577526 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
Not 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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

A portable electronic device designed to automatically detect cardiac arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) in a sudden cardiac arrest (SCA) patient, after which it audibly/visually instructs an operator to enable it to activate defibrillation of the heart through application of electrical shocks to the chest surface. It is placed in conspicuous public locations and is intended to be operated by a layperson.

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 327eac80-5061-42ec-8c65-43ec288777e0 36 fields · synced Jul 8, 2026