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HeartStart

FDA UDI

Class III (US FDA UDI)

by Philips Electronics North America Corporation

Identity

Trade Name
HeartStart FDA UDI
Generic Name
Rechargeable professional automated external defibrillator FDA UDI
Device Name
Philips System Case, Rigid, FR3 FDA UDI
Model / Reference
FR3 System Case, Ridge FDA UDI
Description
Philips System Case, Rigid, FR3 FDA UDI

Identifiers

Catalog Number
989803149971 FDA UDI
Primary DI / UDI-DI
00884838055704 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Rechargeable professional automated external defibrillator

HeartStart 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 d1400b88-eaf4-45b9-8eaa-2bdea533595e 35 fields · synced May 30, 2026