Amco

FDA UDI

Class III (US FDA UDI)

by Amco International Manufacturing & Design, Inc.

Identity

Trade Name: AMCO FDA UDI
Generic Name: Primary battery FDA UDI
Device Name: Lithium replacement battery for Cardiac Science(TM) Powerheart(TM) AED G3 9300A,, 9300E shipped after April 12, 2004, with 4 year full replacement guarantee. Color white. FDA UDI
Model / Reference: AM9146-1 FDA UDI
Description: Lithium replacement battery for Cardiac Science(TM) Powerheart(TM) AED G3 9300A,, 9300E shipped after April 12, 2004, with 4 year full replacement guarantee. Color white. FDA UDI

Identifiers

Catalog Number: AM9146-1 FDA UDI
Primary DI / UDI-DI: 00853258006023 FDA UDI
510(k) Number: K082861 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

Yes

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Primary battery

Amco by Amco International Manufacturing & Design, Inc. — 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

K082861 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Amco International Manufacturing & Design, Inc.

Sources (1)

FDA UDI c5c45fcc-5a09-4e92-909e-502f69c35bf3 36 fields · synced May 30, 2026