FDA.reportPublic FDA data

AED Battery Exchange

Primary DI
00197644380145
Brand
AED Battery Exchange
Company
AED BATTERY EXCHANGE, LLC
Model
DBP-2003-ABE
Device description
Lithium Manganese Dioxide battery for replacement in Defibtech VIEW DDU-2300, View DDU-2200, ECG DDU-2450, and ECG+ DDU-2475
Published
2026-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MKJAutomated External Defibrillators (Non-Wearable)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MKJAutomated External Defibrillators (Non-Wearable)Cardiovascular3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P190013001

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P190013001AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE)Aed Battery Exchange, LLC2021-02-02MKJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197644380145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197644380145001976443801451976443801450197644380145

GMDN Terms#

Term, Definition table
TermDefinition
Primary battery"A non-rechargeable set of electrochemical cells, or a single cell, designed to store chemical energy and release it in the form of electrical energy to provide power for active implantable medical devices or external medical instruments, for backup power for programmable devices that must retain electronic information, or to power portable or other medical devices when it is not possible or convenient to use the line supply. The device includes terminals and may include a case. The size, shape, and chemical composition of the device should be specified according to the requirements in ""IEC 60086-1 Primary batteries - Part 1: General"", or the latest version of this standard."

Regulatory Flags#

DUNS number
039840984
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00864312000291AED Battery ExchangeDBP-1400-ABE2026-04-15
00864312000277AED Battery ExchangeFR3-ABE2021-02-25
00864312000284AED Battery ExchangeG5-ABE2021-02-25
00864312000208AED Battery Exchange5070-ABE2016-03-08
00864312000215AED Battery Exchange3863-ABE2016-03-08
00864312000222AED Battery Exchange500-ABE2016-03-08
00864312000239AED Battery Exchange9146-Y-ABE2016-03-08
00864312000246AED Battery Exchange9146-B-ABE2016-03-08
00864312000253AED Battery Exchange9146-W-ABE2016-03-08
00864312000260AED Battery Exchange9141-ABE9141-ABE2016-03-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810149098291R&D Batteries, Inc.R & D Batteries, Inc.MKJ2026-04-01
10847946001435PEDI PADZZoll Medical CorporationMKJ2026-02-12
10847946016231ONESTEPZoll Medical CorporationMKJ2026-02-12
10847946023345ONESTEPZoll Medical CorporationMKJ2026-02-12
00810149098208R&D Batteries, Inc.R & D Batteries, Inc.MKJ2025-11-19
20192253017516KendallCardinal Health 200, LLCMKJ2024-02-28
20192253017530KendallCardinal Health 200, LLCMKJ2024-02-28
20192253017561Medi-Trace CadenceCardinal Health 200, LLCMKJ2024-02-28
20192253017608Medi-Trace CadenceCardinal Health 200, LLCMKJ2024-02-28
10009336010322Zoll PL DefibGRAPHIC CONTROLS ACQUISITION CORPMKJ2023-10-30
10653405046813CONMEDConmed CorporationMKJ2023-10-19
20192253017714KendallCardinal Health 200, LLCMKJ2023-06-15
10884838002859HeartStartPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2022-02-25
10884838002842HeartStart Adult/Child Plus PadsPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2022-01-06
10884838002866HeartStartPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2022-01-06
10884838022048Adult/Child Pre-Connect Defib PadPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2022-01-06
20192253017554Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-08-19
20192253017622Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-08-19
20192253018865Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-08-19
20192253017578Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-07-29
20192253017585Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-07-29
20192253017639Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-07-29
20192253018872Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-07-29
20192253018889Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-07-29
20192253017547Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-07-28
20192253017295KendallCardinal Health 200, LLCMKJ2021-05-06
20192253017455KendallCardinal Health 200, LLCMKJ2021-05-05
20192253017721KendallCardinal Health 200, LLCMKJ2021-05-05
20192253017745KendallCardinal Health 200, LLCMKJ2021-05-05
10888277634978MedlineMEDLINE INDUSTRIES, INC.MKJ2020-08-21