Heart Sync Adult/Child Radio Transparent Multi Function Electrodes

FDA UDI

Class II (US FDA UDI)

by Heart Sync Inc

Identity

Trade Name: Heart Sync Adult/Child Radio Transparent Multi Function Electrodes FDA UDI
Generic Name: Electrode conductive skin pad, single-use FDA UDI
Device Name: The Heart Sync Adult/Child Radio Transparent Multi Function Electrodes are indicated for use in external pacing, defibrillation and monitoring applications,as a disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients (>22lbs/10kg). When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum). Compatible with Anderson Connector adapted models of monophasic and bi-phasic defibrillators. FDA UDI
Model / Reference: C100AC FDA UDI
Description: The Heart Sync Adult/Child Radio Transparent Multi Function Electrodes are indicated for use in external pacing, defibrillation and monitoring applications,as a disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients (>22lbs/10kg). When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum). Compatible with Anderson Connector adapted models of monophasic and bi-phasic defibrillators. FDA UDI

Identifiers

Catalog Number: C100AC FDA UDI
Primary DI / UDI-DI: 00868866000042 FDA UDI
FDA Product Code: MLN FDA UDI
GMDN Term: Electrode conductive skin pad, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2360 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

Yes

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Manufacturing Date

FDA UDI

Category: Electrode conductive skin pad, single-use

Heart Sync Adult/Child Radio Transparent Multi Function Electrodes are a non-invasive, disposable pacemaker electrode system designed for adult and child patients. These transparent, multi-functional electrodes facilitate electrical conduction between an external defibrillator or cardiac pacemaker and the patient's skin. The device is intended for single-patient use and provides durable protection against corrosion.

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Heart Sync Inc

Sources (1)

FDA UDI dfca0579-7a56-4799-acf4-62d4d86173c7 36 fields · synced Jul 2, 2026