FDA.reportPublic FDA data

ALPHA SOURCE BATTERY

Primary DI
00814314011238
Brand
ALPHA SOURCE BATTERY
Company
ALPHA SOURCE INC.
Model
4200-84-1
Catalog number
4200-84-1
Device description
6V 4.5AH SLA BATTERY
Published
2019-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K032051000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032051000BATTERY PACK, RECHARGEABLE, MODELS MLA0051, MLA90479, MNC5169L/P, MNC1000EKG, MNC14649PAccess Battery, Inc.2004-01-09MKJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814314011238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814314011238008143140112388143140112380814314011238

GMDN Terms#

Term, Definition table
TermDefinition
Secondary batteryA 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 size, shape, and chemical composition of the battery should be specified according to the requirements of the appropriate IEC standard.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
154199392
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814314010071ALPHA SOURCE BATTERYAS35092AS350922019-07-02
00814314011726ALPHA SOURCE BATTERYAS01099-KIT-1AS01099-KIT-12019-07-02
00814314012211ALPHA SOURCE BATTERYAS01099-KIT-3AS01099-KIT-32019-07-02
00814314010132ALPHA SOURCE BATTERYAS30289AS302892019-07-01
00814314010200ALPHA SOURCE BATTERYAS35389AS353892019-07-01
00814314011047ALPHA SOURCE BATTERYAS30139AS301392019-07-01
00814314011177ALPHA SOURCE BATTERYAS10782AS107822019-07-01
00814314011399ALPHA SOURCE BATTERYAS36011AS360112019-07-01
00814314011573ALPHA SOURCE BATTERYAS35010AS350102019-07-01
00814314011627ALPHA SOURCE BATTERYAS35943AS359432019-07-01
00814314011634ALPHA SOURCE BATTERYAS36036AS360362019-07-01
00814314011818ALPHA SOURCE BATTERY4500-84-14500-84-12019-07-01
00814314011870ALPHA SOURCE BATTERYAS36053AS360532019-07-01
00814314012068ALPHA SOURCE BATTERYAS10010AS100102019-07-01
00814314012280ALPHA SOURCE BATTERYAS35003AS350032019-07-01
00814314012518ALPHA SOURCE BATTERYAS35955AS359552019-07-01
00814314014062ALPHA SOURCE BATTERYAS36093AS360932019-07-01
00814314014611ALPHA SOURCE BATTERYAS30278AS302782019-07-01
00814314014727ALPHA SOURCE BATTERYAS36209AS362092019-07-01
00814314015182ALPHA SOURCE BATTERYAS35106AS351062019-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812394027279RADIOTRANSPARENT DEFIBRILLATION ELECTRODEZoll Medical CorporationMKJ2026-05-29
10812394027276RADIOTRANSPARENT DEFIBRILLATION ELECTRODEZoll Medical CorporationMKJ2026-05-29
00197644380145AED Battery ExchangeAED BATTERY EXCHANGE, LLCMKJ2026-04-15
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