Identity
- Trade Name
- Intellisense® Battery Powerheart® G5 FDA UDI
- Generic Name
- Primary battery FDA UDI
- Device Name
- Intellisense non-rechargeable battery for Powerheart G5 AED with 4 year full replacement guarantee FDA UDI
- Model / Reference
- XBTAED001A FDA UDI
- Description
- Intellisense non-rechargeable battery for Powerheart G5 AED with 4 year full replacement guarantee FDA UDI
Identifiers
- Catalog Number
- XBTAED001A FDA UDI
- Primary DI / UDI-DI
- 00812394020904 FDA UDI
- 510(k) Number
- K122758 FDA UDI
- FDA Product Code
- MKJ FDA UDI
- GMDN Term
- Primary battery 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Primary battery
Intellisense® Battery Powerheart® G5 by Zoll Medical Corporation — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- R&D Batteries, Inc. — R & D BATTERIES, INC. · Class III
- LIFEPAK® 500 Li-SO2 Non-Rechargeable Battery — PHYSIO-CONTROL, Inc. · Class III
- R&D Batteries, Inc. — R & D BATTERIES, INC. · Class III
- R&D Batteries, Inc. — R & D BATTERIES, INC. · Class III
- AMCO — AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. · Class III
- DDU-1XX Series Battery Pack Configuration — 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 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
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 aab140d1-b478-4aee-b183-dfa3904e69d7 36 fields · synced Jun 8, 2026