Identity
- Trade Name
- Powerheart G5 Kit, Semi, US Eng/ESP LA FDA UDI
- Generic Name
- Non-rechargeable public semi-automated external defibrillator FDA UDI
- Device Name
- Powerheart G5 AED, Semi Automatic, Dual Language (English/Spanish),no battery or pads FDA UDI
- Model / Reference
- G5S-80P0 FDA UDI
- Description
- Powerheart G5 AED, Semi Automatic, Dual Language (English/Spanish),no battery or pads FDA UDI
Identifiers
- Catalog Number
- G5S-80P0 FDA UDI
- Primary DI / UDI-DI
- 00812394020560 FDA UDI
- 510(k) Number
- K122758 FDA UDI
- FDA Product Code
- MKJ FDA UDI
- GMDN Term
- Non-rechargeable public semi-automated external defibrillator 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Non-rechargeable public semi-automated external defibrillator
Powerheart G5 Kit, Semi, US Eng/ESP LA by Cardiac Science Corporation — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-rechargeable public semi-automated external defibrillator.
- Powerheart® G5 TSO Kit, Semi, US EN/LA ESP — Zoll Medical Corporation · Class III
- AED PLUS — Zoll Medical Corporation · Class III
- Powerheart® AED G3 Plus Semi Automatic — Zoll Medical Corporation · Class III
- AED PLUS — Zoll Medical Corporation · Class III
- Powerheart® AED G3 Pro AED — Zoll Medical Corporation · Class III
- samaritan PAD — HEARTSINE TECHNOLOGIES LTD · Class III
- LIFEPAK — PHYSIO-CONTROL, Inc. · Class III
- DDU-100 Lifeline AED with RX form and cabinet — DEFIBTECH, L.L.C. · Class III
Cleared under the same submission
K122758 also covers:
- AED Manager, V.2.0.5.0 Powerheart G5 — Cardiac Science Corporation
- 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 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 |
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Manufacturer
- Manufacturer
- Cardiac Science Corporation
Sources (1)
- FDA UDI 7dc80883-6614-416f-87f9-75376288bb21 37 fields · synced Jun 1, 2026