Identity
- Trade Name
- Powerheart® MDLink FDA UDI
- Generic Name
- External defibrillator application software FDA UDI
- Device Name
- MDLink SW 12.0 FDA UDI
- Model / Reference
- 40-00580-01 FDA UDI
- Description
- MDLink SW 12.0 FDA UDI
Identifiers
- Catalog Number
- 40-00580-01 FDA UDI
- Primary DI / UDI-DI
- 00812394021499 FDA UDI
- FDA Product Code
- MKJ FDA UDI
- GMDN Term
- External defibrillator application software 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: External defibrillator application software
Powerheart® MDLink by Zoll Medical Corporation — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as External defibrillator application software.
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- AED Manager, V.2.2.1.1 Powerheart G5 — Zoll Medical Corporation · Class III
- AED Manager, V.2.1.1.0 Powerheart G5 — Zoll Medical Corporation · Class III
- Powerheart® MDLink — Zoll Medical Corporation · Class III
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
- Zoll Medical Corporation
Sources (1)
- FDA UDI 9168b1e8-fe16-4d04-a639-b7467fc7e4db 35 fields · synced Jun 8, 2026