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AED Brands, LLC

FDA UDI

Class III (US FDA UDI)

by Aed Brands, Llc

Identity

Trade Name
AED Brands, LLC FDA UDI
Generic Name
Primary battery FDA UDI
Device Name
Battery for use with Cardiac Science(TM) G3 series AEDs FDA UDI
Model / Reference
AB 9146-302 FDA UDI
Description
Battery for use with Cardiac Science(TM) G3 series AEDs FDA UDI

Identifiers

Primary DI / UDI-DI
00865292000127 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

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

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.

Cleared under the same submission

K082861 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Aed Brands, Llc

Sources (1)

  • FDA UDI 5839323e-f31c-4107-bf49-234bd3ee0cea 35 fields · synced May 30, 2026