Identity
- Trade Name
- AED Manager, V.2.0.5.0 Powerheart G5 FDA UDI
- Generic Name
- External defibrillator application software FDA UDI
- Device Name
- Event Reporting and Administrative AED Configuration Software V 2 0 5 0 for Powerheart G5 FDA UDI
- Model / Reference
- XAEDMGR01C FDA UDI
- Description
- Event Reporting and Administrative AED Configuration Software V 2 0 5 0 for Powerheart G5 FDA UDI
Identifiers
- Catalog Number
- XAEDMGR01C FDA UDI
- Primary DI / UDI-DI
- 00812394020539 FDA UDI
- 510(k) Number
- K122758 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
AED Manager, V.2.0.5.0 Powerheart G5 by Cardiac Science Corporation — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as External defibrillator application software.
- AED Manager, V.2.2.1.1 Powerheart G5 — Zoll Medical Corporation · Class III
- Powerheart® MDLink — 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
- Saver EVO — HEARTSINE TECHNOLOGIES LTD · Class III
- Powerheart® MDLink — Cardiac Science Corporation · Class III
- AED Manager, Powerheart G5 — Cardiac Science Corporation · Class III
Cleared under the same submission
K122758 also covers:
- Intellisense Adult Defibrillation Pads, Powerheart® G5 — Cardiac Science Corporation
- Intellisense Adult Defibrillation Pads, Powerheart® G5 — Cardiac Science Corporation
- Intellisense® Battery Powerheart® G5 — Cardiac Science Corporation
- Intellisense™ Pediatric Defibrillation Pads Powerheart® G5 — Cardiac Science Corporation
- Intellisense™ Pediatric Defibrillation Pads Powerheart® G5 — Cardiac Science Corporation
- Powerheart G5 Kit, Semi, US Eng/ESP LA — Cardiac Science Corporation
- Powerheart® G5 Automatic AED — Cardiac Science Corporation
- Powerheart® G5 Automatic AED — Cardiac Science Corporation
- Powerheart® G5 Semi Automatic AED — Cardiac Science Corporation
- AED Manager, V.2.1.1.0 Powerheart G5 — Zoll Medical Corporation
- Intellisense Adult Defibrillation Pads, Powerheart® G5 — Zoll Medical Corporation
- Intellisense Adult Defibrillation Pads, Powerheart® G5 — Zoll Medical Corporation
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cardiac Science Corporation
Sources (1)
- FDA UDI b607e94c-f25c-4ef0-a39e-e8ec8e9348e8 35 fields · synced May 30, 2026