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HeartStart

FDA UDI

Class II (US FDA UDI)

by Philips Electronics North America Corporation

Identity

Trade Name
HeartStart FDA UDI
Generic Name
Internal defibrillation electrode, adult, reusable FDA UDI
Model / Reference
989803210531 FDA UDI

Identifiers

Catalog Number
989803210531 FDA UDI
Primary DI / UDI-DI
00884838106635 FDA UDI
FDA Product Code
LDD FDA UDI
GMDN Term
Internal defibrillation electrode, adult, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.5300 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Internal defibrillation electrode, adult, reusable

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

Similar devices

Also classified as Internal defibrillation electrode, adult, reusable.

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 b47a4778-a6a8-4686-b3cf-b202bf520e19 34 fields · synced Jun 8, 2026