HeartStart FRx Defibrillator and HeartStart SMART Pads II

FDA PMAFDA UDIEUDAMED

Class III (US FDA PMA)

PMA P180028Ref 989803139261

by Philips Medical Systems

Identity

Trade Name: FRx Smart Pads II EUDAMED
HeartStart FRx Defibrillator FDA PMA
PHILIPS HeartStart SMARTPADS II FDA UDI
Generic Name: Automated external defibrillators (non-wearable) FDA PMA
Multifunction cardiac treatment electrode FDA UDI
Device Name: ALS and BLS Defib Pads and Electrodes EUDAMED
SMART Pads II FDA UDI
Model / Reference: 989803139261 EUDAMED
FRx Smart Pads II FDA UDI
Description: SMART Pads II FDA UDI

Identifiers

Catalog Number: 989803139261 FDA UDI
Primary DI / UDI-DI: 00884838023703 EUDAMEDFDA UDI
Basic UDI-DI: 0884838BM480T6 EUDAMED
PMA Number: P180028 FDA PMA
FDA Product Code: MKJ FDA PMAFDA UDI
MLN FDA UDI
EMDN Code: Z12030585 DEFIBRILLATORS - CONSUMABLES EUDAMED
GMDN Term: Multifunction cardiac treatment electrode FDA UDI

Classification

Device Class: Class I EUDAMED
Class III FDA PMAFDA UDI
Legislation / Framework: 21 CFR Part 870.5310 FDA PMA
Regulation Number: 870.5310 FDA PMAFDA UDI
870.2360 FDA UDI
Market of Registration: Austria EUDAMED
Advisory Committee: Cardiovascular FDA PMA
FDA Decision: APPR Approved FDA PMA
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

The HeartStart FRx Defibrillator (Model 861304) is an automated external defibrillator designed to provide life-saving therapy to victims of sudden cardiac arrest. It is indicated for use on patients exhibiting symptoms of unconsciousness and an absence of normal breathing.

This device is indicated for adults weighing over 55 pounds (25 kg). For infants and children under 55 pounds or 8 years of age, the device is used in conjunction with the optional Infant/Child Key (Model 989803139311). If the key is unavailable or the patient's age or weight is uncertain, adult treatment protocols should be followed.

Frequently asked questions

Who can be treated with the HeartStart FRx Defibrillator?

The device is indicated for adults weighing over 55 pounds (25 kg). It can also be used on infants and children under 55 pounds or 8 years old when the optional Infant/Child Key is utilized.

What should I do if I do not have the Infant/Child Key for a pediatric patient?

If the Infant/Child Key (Model 989803139311) is not available, or if you are uncertain of the child's age or weight, you should proceed using the standard adult treatment protocol.

What symptoms indicate the need for this defibrillator?

The device is indicated for use on potential victims of sudden cardiac arrest who are unconscious and demonstrate an absence of normal breathing.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: HeartStart FRx Automated external defibrillator - Philips, FRX AED Smart Pads II 989803139261 - IndiaMART, Philips HeartStart Adult SMART Pads II Original 989803139261, Amazon.com: Philips HeartStart FRx Replacement Smart Pads II, for ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

European Union Active

MDD

United States Active

FDA_PMA

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class III	Active
EUDAMED	European Union	MDD	—	Class III	Active
FDA PMA	United States	FDA_PMA	P180028	Class III	Active

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Manufacturer

Manufacturer: Philips Medical Systems

Sources (3)

FDA PMA P180028 24 fields · synced Sep 18, 2026
FDA UDI 834d8e50-5713-49ae-9415-52c796de3d0e 35 fields · synced May 30, 2026
EUDAMED 0105abd0-8fdf-48b7-8c4d-b87e9f0f84c5 61 fields · synced Jul 24, 2026