FDA.reportPublic FDA data

Anybattery

Primary DI
00856096008044
Brand
Anybattery
Company
ANYBATTERY, INC
Model
4043
Catalog number
4043
Device description
6v / SLA
Published
2019-01-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
MOXBatteries, Rechargeable, For Class 2 Devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)Cardiovascular2
MOXBatteries, Rechargeable, For Class 2 Devices

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160667000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160667000Anybattery C2 Rechargeable BatteryAnybattery, Inc.2017-05-11DPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856096008044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856096008044008560960080448560960080440856096008044

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
005272799
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810179320966Anybattery820882082026-01-20
00810179320959Anybattery880388032025-04-21
00810179320010Anybattery864486442024-09-23
00810179320027Anybattery8416-i8416-i2024-09-23
00810179320034Anybattery469546952024-09-23
00810179320041Anybattery894189412024-09-23
00810179320058Anybattery8055-58055-52024-09-23
00810179320065Anybattery869286922024-09-23
00810179320072Anybattery879487942024-09-23
00810179320089Anybattery894289422024-09-23
00810179320096Anybattery870487042024-09-23
00810179320102Anybattery887288722024-09-23
00810179320119Anybattery881288122024-09-23
00810179320126Anybattery853585352024-09-23
00810179320133Anybattery833383332024-09-23
00810179320140Anybattery864886482024-09-23
00810179320157Anybattery869786972024-09-23
00810179320164Anybattery139613962024-09-23
00810179320171Anybattery829482942024-09-23
00810179320188Anybattery826982692024-09-23

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Primary DI, Brand, Company table
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