← Back to catalogue

Adult/Child, radiotransparent, defib electrodes with increased adhesive surface

FDA UDIFDA 510(k)

Class II (US FDA UDI)

510(k) K131494

by Heart Sync Inc

Identity

Trade Name
Adult/Child, radiotransparent, defib electrodes with increased adhesive surface 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 non-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/child 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 Philips Plug Style connector models of monophasic and bi-phasic defibrillators. FDA UDI
Model / Reference
C300AC-PHILIPS 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 non-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/child 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 Philips Plug Style connector models of monophasic and bi-phasic defibrillators. FDA UDI

Identifiers

Catalog Number
C300AC-PHILIPS FDA UDI
Primary DI / UDI-DI
00854664006171 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

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Electrode conductive skin pad, single-use

Adult/Child, radiotransparent, defib electrodes with increased adhesive surface by Heart Sync Inc — Class II — FDA_510K — listed in FDA GUDID, FDA 510(k)

Similar devices

Also classified as Electrode conductive skin pad, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Heart Sync Inc
FDA Applicant
Heart Sync, Inc.

Sources (2)

  • FDA UDI 36741457-0dfe-4246-831c-32e15719340d 60 fields · synced Jun 18, 2026
  • FDA 510(k) K131494 1 fields · synced May 22, 2026