FDA.reportPublic FDA data

ALPHA SOURCE BATTERY

Primary DI
00814314013324
Brand
ALPHA SOURCE BATTERY
Company
ALPHA SOURCE INC.
Model
AS35102
Catalog number
AS35102
Device description
12V 2.8AH SLA BATTERY
Published
2019-06-20
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
FRNPump, Infusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRNPump, InfusionGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K922909000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K922909000MEDICAL BATTERY PACKSAccess / God Loves You1992-09-23FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814314013324PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814314013324008143140133248143140133240814314013324

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
08500835120017Avoset Optum Homecare InfusionOptum Distribution Center, LLCFRN2026-02-24
17290109155309Sapphire M.T. Pump Kit CEITAN MEDICAL LTDFRN2024-09-04
30815112021345Elution Test Vial Bracco Diagnostics Inc.FRN2024-02-13
10815112021396CardioGen-82 Infusion System Model 1700Bracco Diagnostics Inc.FRN2023-12-01
10815112021358CardioGen Patient Administration SetBracco Diagnostics Inc.FRN2023-10-16
17290109155149Sapphire Epidural Infusion Kit - US EITAN MEDICAL LTDFRN2023-09-05
30815112021338Accessory PackageBracco Diagnostics Inc.FRN2023-06-29
30815112020034Accessory PackageBracco Diagnostics Inc.FRN2023-03-22
30815112020614Accessory PackageBracco Diagnostics Inc.FRN2023-03-22
17290109154272Sapphire Epidural Infusion Pump Kit – USEITAN MEDICAL LTDFRN2022-05-15
17290109154289Sapphire M.T Infusion Pump Kit- US - S kit EITAN MEDICAL LTDFRN2022-05-15
17290109154265Sapphire M.T Infusion Pump Kit – USEITAN MEDICAL LTDFRN2022-05-11
10814844000365Curlin IV Pump SystemZEVEX INTERNATIONAL, INC.FRN2021-04-29
15019517177367PharmGuardICU MEDICAL, INC.FRN2020-03-20
15019517177374PharmGuardICU MEDICAL, INC.FRN2020-03-20
10884521064843KangarooCardinal Health, Inc.FRN2019-12-30
15019517155143MEDFUSIONICU MEDICAL, INC.FRN2019-09-20
15019517155150MEDFUSIONICU MEDICAL, INC.FRN2019-09-20
15019517155167MEDFUSIONICU MEDICAL, INC.FRN2019-09-20
15019517178067MedfusionICU MEDICAL, INC.FRN2019-09-18
20763000273334MiniMed™ ReservoirMEDTRONIC MINIMED, INC.FRN2019-09-02
20763000273358MiniMed™ ReservoirMEDTRONIC MINIMED, INC.FRN2019-09-02
M33513852011Plum 360ICU MEDICAL, INC.FRN2019-02-15
70643169771481MiniMed™ ReservoirMEDTRONIC MINIMED, INC.FRN2018-05-31
08050616611635APO-GO Syringe reservoirCANE' SPAFRN2018-05-28
17290109150229SapphirePlus Infusion Kit - USEITAN MEDICAL LTDFRN2018-02-22
09350902001614Flow Control TubingGO MEDICAL INDUSTRIES PTY. LTD.FRN2017-05-18
09350902001690Flow Control TubingGO MEDICAL INDUSTRIES PTY. LTD.FRN2017-05-18
09350902001720Flow Control TubingGO MEDICAL INDUSTRIES PTY. LTD.FRN2017-05-18
09350902001751Flow Control TubingGO MEDICAL INDUSTRIES PTY. LTD.FRN2017-05-18