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Heart Sync Adult Radio Transparent Multi Function Electrodes
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Heart Sync Adult 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/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 Physio Control quik combo® adapted models of monophasic and bi-phasic defibrillators. FDA UDI
- Model / Reference
- C100AC-Physio 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/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 Physio Control quik combo® adapted models of monophasic and bi-phasic defibrillators. FDA UDI
Identifiers
- Catalog Number
- C100AC-Physio FDA UDI
- Primary DI / UDI-DI
- 00868866000066 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
Heart Sync Adult Radio Transparent Multi Function Electrodes by Heart Sync Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 36b9fb6e-3b30-4bca-ae2a-ed37bad3c9c0 36 fields · synced Jun 6, 2026