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PHILIPS HeartStart FR3

FDA UDI

Class III (US FDA UDI)

by Philips Electronics North America Corporation

Identity

Trade Name
PHILIPS HeartStart FR3 FDA UDI
Generic Name
Rechargeable professional automated external defibrillator FDA UDI
Device Name
HeartStart FR3 Defibrillator FDA UDI
Model / Reference
HeartStart FR3 FDA UDI
Description
HeartStart FR3 Defibrillator FDA UDI

Identifiers

Catalog Number
861389 FDA UDI
Primary DI / UDI-DI
00884838049994 FDA UDI
FDA Product Code
MKJ FDA UDI
GMDN Term
Rechargeable professional 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

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Rechargeable professional automated external defibrillator

PHILIPS HeartStart FR3 by Philips Electronics North America Corporation — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rechargeable professional automated external defibrillator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Philips Electronics North America Corporation

Sources (1)

  • FDA UDI 1bb82eea-2c52-4f4d-9345-6f6a211c1421 35 fields · synced Jun 1, 2026