FDA.reportPublic FDA data

ALPHA SOURCE BATTERY

Primary DI
00814314011733
Brand
ALPHA SOURCE BATTERY
Company
ALPHA SOURCE INC.
Model
AS10634
Catalog number
AS10634
Device description
12V 250MAH NIMH BATTERY
Published
2019-06-20
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
HGMSystem, Monitoring, Perinatal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGMSystem, Monitoring, PerinatalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030261000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030261000BATTERY, RECHARGEABLEAccess Battery, Inc.2003-04-24HGM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814314011733PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814314011733008143140117338143140117330814314011733

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
Donation ID number
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B153301010AirStrip ONE Client iOSAirstrip Technologies, Inc.HGM2026-03-18
B153301020AirStrip ONE Client AndroidAirstrip Technologies, Inc.HGM2026-03-18
05051968048233SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048240SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048257SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048264SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048271SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048288SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048295OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048301OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048318OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048325OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048332OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048349OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
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05051968048363OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
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05051968048387OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048394OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048400OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048417OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048424OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048431OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
06944413814714Trolley(For medical use)Edan Instruments, Inc.HGM2025-12-09
06944413819726Trolley(For medical use)Edan Instruments, Inc.HGM2025-12-09
06944413819733Trolley(For medical use)Edan Instruments, Inc.HGM2025-12-09
06944413807112Remote Event MarkerEdan Instruments, Inc.HGM2025-11-29
00860003483565PeriWatch SurveillancePERIGEN INC.HGM2025-11-24
00198953043271CareIntellect PerinatalGe Medical Systems Information Technologies, Inc.HGM2025-11-21