Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes

FDA UDI

Class III (US FDA UDI)

by Heart Sync Inc

Identity

Trade Name: Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes FDA UDI
Generic Name: Electrode conductive skin pad, single-use FDA UDI
Device Name: The Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a sterile, 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" adapted models of monophasic and bi-phasic defibrillators. FDA UDI
Model / Reference: Sterile-C100 FDA UDI
Description: The Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a sterile, 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" adapted models of monophasic and bi-phasic defibrillators. FDA UDI

Identifiers

Catalog Number: Sterile-C100 FDA UDI
Primary DI / UDI-DI: 00868866000035 FDA UDI
FDA Product Code: MKJ FDA UDI
GMDN Term: Electrode conductive skin pad, single-use FDA UDI

Classification

Device Class: Class III FDA UDI
Regulation Number: 870.5310 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

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Manufacturing Date

FDA UDI

Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes by Heart Sync Inc — Class III — FDA UDI — listed in FDA GUDID

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 III	Pending data

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Manufacturer

Manufacturer: Heart Sync Inc

Sources (1)

FDA UDI 39576116-aa4e-4d00-a6bc-57bcffce52c3 37 fields · synced May 30, 2026