Identity
- Trade Name
- AED Brands, LLC FDA UDI
- Generic Name
- Primary battery FDA UDI
- Device Name
- Battery for use with Cardiac Science AEDs FDA UDI
- Model / Reference
- AB 9146-302 FDA UDI
- Description
- Battery for use with Cardiac Science AEDs FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00865292000141 FDA UDI
- 510(k) Number
- K120350 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 1.2 Pound FDA UDI
Category: Primary battery
AED Brands, LLC by Aed Brands, Llc — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Primary battery.
- 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
- LIFEPAK® 500 Li-SO2 Non-Rechargeable Battery — PHYSIO-CONTROL, Inc. · Class III
- Intellisense® Battery Powerheart® G5 — Zoll Medical Corporation · Class III
- R&D Batteries, Inc. — R & D BATTERIES, INC. · Class III
- R&D Batteries, Inc. — R & D BATTERIES, INC. · Class III
- Powerheart® G3 Battery — Zoll Medical Corporation · Class III
Cleared under the same submission
K120350 also covers:
- AED Battery Exchange — AED Battery Exchange, LLC
- AED Battery Exchange — AED Battery Exchange, LLC
- AED Battery Exchange — AED Battery Exchange, LLC
- AED Battery Exchange — AED Battery Exchange, LLC
- AED Battery Exchange — AED Battery Exchange, LLC
- AED Battery Exchange — AED Battery Exchange, LLC
- AED Battery Exchange — AED Battery Exchange, LLC
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
- Aed Brands, Llc
Sources (1)
- FDA UDI 0bcaadac-8baa-4d6d-827a-34756d65d085 36 fields · synced May 31, 2026