Identity
- Trade Name
- AED Battery Exchange FDA UDI
- Generic Name
- Primary battery FDA UDI
- Device Name
- Lithium Manganese Dioxide battery for replacement in Philips(TM) HeartStart(TM) FR2 and FR2+ FDA UDI
- Model / Reference
- 3863-ABE FDA UDI
- Description
- Lithium Manganese Dioxide battery for replacement in Philips(TM) HeartStart(TM) FR2 and FR2+ FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00864312000215 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
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Primary battery
AED Battery Exchange by AED Battery Exchange, 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 Brands, LLC — AED BRANDS, 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 |
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Manufacturer
- Manufacturer
- AED Battery Exchange, LLC
Sources (1)
- FDA UDI ccd401bc-acbc-4c8c-8f77-51bd528c572c 34 fields · synced May 30, 2026