Identity
- Trade Name
- Heartsync by Vermed FDA UDI
- Generic Name
- External defibrillation electrode, adult, single-use FDA UDI
- Device Name
- DEFIB ELECTRODE FDA UDI
- Model / Reference
- T100AC-ZOLL-10 FDA UDI
- Description
- DEFIB ELECTRODE FDA UDI
Identifiers
- Catalog Number
- 6600096H FDA UDI
- Primary DI / UDI-DI
- 00009336009664 FDA UDI
- FDA Product Code
- MKJ FDA UDI
- GMDN Term
- External defibrillation electrode, adult, single-use FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 870.5310 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: External defibrillation electrode, adult, single-use
Heartsync by Vermed by Graphic Controls Acquisition Corp — Class III — 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 III | Pending data |
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Manufacturer
- Manufacturer
- Graphic Controls Acquisition Corp
Sources (1)
- FDA UDI 86d540a9-2769-48bd-9a21-622695775c13 36 fields · synced Jun 7, 2026