AED Battery Exchange

FDA UDI

Class III (US FDA UDI)

by AED Battery Exchange, LLC

Identity

Trade Name: AED Battery Exchange FDA UDI
Generic Name: Primary battery FDA UDI
Device Name: Lithium - Sulfur Dioxide battery for replacement in Cardiac Science(TM) Powerheart(TM) 9200RD, 9210RD AT, and Survivalink Firstsave(TM) 9100, 9110, 9200, 9210, 9200D, and 9210D FDA UDI
Model / Reference: 9141-ABE FDA UDI
Description: Lithium - Sulfur Dioxide battery for replacement in Cardiac Science(TM) Powerheart(TM) 9200RD, 9210RD AT, and Survivalink Firstsave(TM) 9100, 9110, 9200, 9210, 9200D, and 9210D FDA UDI

Identifiers

Catalog Number: 9141-ABE FDA UDI
Primary DI / UDI-DI: 00864312000260 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

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:

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 2634a35c-f0da-4924-af91-4de8bdbdbc15 35 fields · synced Jun 8, 2026