FDA.reportPublic FDA data

ALPHA SOURCE BATTERY

Primary DI
00814314010132
Brand
ALPHA SOURCE BATTERY
Company
ALPHA SOURCE INC.
Model
AS30289
Catalog number
AS30289
Device description
8.4V 8.0AH NIMH BATTERY
Published
2019-07-01
Public version status
Update
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
00814314010132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814314010132008143140101328143140101320814314010132

GMDN Terms#

Term, Definition table
TermDefinition
Rechargeable battery packA group of rechargeable batteries held within a holder or container intended to provide temporary electrical energy to operate a medical device, typically when it is not possible, intentional, or convenient to connect the device being powered to a mains electricity (AC-powered) electrical outlet. It is typically used during a transport situation (e.g., a neonatal incubator), or when the device is designed to power a cordless devices (e.g., an endoscopic device or a rechargeable battery-powered surgical drilling system handpiece). This is a reusable device.

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
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
00814314010255ALPHA SOURCE BATTERYAS36296-IAS36296-I2019-06-20

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