FDA.reportPublic FDA data

Aether Battery System

Primary DI
05904569152222
Brand
Aether Battery System
Company
AETHER BIOMEDICAL SP Z O O
Model
AET-BAT-BS1
Device description
The Battery system is a device which allows supply an energy to prosthetic hand . The Aether Battery System consists of a battery pack AET-BAT with the necessary interconnections.
Published
2023-01-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IQZHand, External Limb Component, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQZHand, External Limb Component, PoweredPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05904569152222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05904569152222059045691522225904569152222

GMDN Terms#

Term, Definition table
TermDefinition
Rechargeable battery packA group of rechargeable batteries held within a holder, container, or mobile cart/trolley 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 it is designed to power a cordless device (e.g., an endoscopic device or a rechargeable battery-powered surgical drilling system handpiece). This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
850705379
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05904569152291ZEUSA-01-L-T2023-03-24
05905515340014ZEUSA-01-R-T2023-03-19
05904569152253Aether Digital PlatformW-ADP2023-10-31
05904569152260Aether Digital PlatformM-ADP2023-10-31
05904569152208ZEUSZeus V1A-01-L2022-04-15
05904569152239ZEUSZeus V1A-01-R2022-04-19
05905515340007ZEUSA-01-L-T2023-03-24
05905515340021ZEUSA-01-R-T2023-03-19
05904569152246ZEUSZeus V1A-01-R2022-04-19
05904569152215ZEUSZeus V1A-01-L2022-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04064411005531Myo Plus TROtto Bock Healthcare Products GmbHIQZ2026-05-04
04064411007672myosmart.Otto Bock Healthcare Products GmbHIQZ2026-05-04
04064411008105myosmart.cuffOtto Bock Healthcare Products GmbHIQZ2026-05-04
04064411008112myosmart.cuffOtto Bock Healthcare Products GmbHIQZ2026-05-04
04064411008129myosmart.cuffOtto Bock Healthcare Products GmbHIQZ2026-05-04
04064411008136myosmart.cuffOtto Bock Healthcare Products GmbHIQZ2026-05-04
04064411009041myosmart.cuffOtto Bock Healthcare Products GmbHIQZ2026-05-04
04064411009058myosmart.cuffOtto Bock Healthcare Products GmbHIQZ2026-05-04
04064411010856myosmart trial kitOtto Bock Healthcare Products GmbHIQZ2026-05-04
04064411013697myosmart trial kitOtto Bock Healthcare Products GmbHIQZ2026-05-04
04064411013772connectgrip.Otto Bock Healthcare Products GmbHIQZ2026-05-04
04064411014144connectgrip.Otto Bock Healthcare Products GmbHIQZ2026-05-04
08057971594702Analog Amplifier with accessoriesBIONIT LABS SRLIQZ2026-03-20
08057971594795Remote Wave ElectrodeBIONIT LABS SRLIQZ2026-03-20
08057971594801Remote Wave ElectrodeBIONIT LABS SRLIQZ2026-03-20
08057971594818Remote Wave ElectrodeBIONIT LABS SRLIQZ2026-03-20
08057971594733Remote Wave ElectrodeBIONIT LABS SRLIQZ2026-03-18
09421037390413TASKA PowerCore System, BlackTASKA PROSTHETICS LIMITEDIQZ2026-01-07
09421037390420TASKA PowerCore System, SandTASKA PROSTHETICS LIMITEDIQZ2026-01-07
09421906785005TASKA HandGen2 Myoelectric Hand - 8 1/4 RH LP WhiteTASKA PROSTHETICS LIMITEDIQZ2026-01-07
09421906785012TASKA HandGen2 Myoelectric Hand - 8 1/4 RH LP BlackTASKA PROSTHETICS LIMITEDIQZ2026-01-07
09421906785029TASKA HandGen2 Myoelectric Hand - 8 1/4 RH LP SandTASKA PROSTHETICS LIMITEDIQZ2026-01-07
09421906785036TASKA HandGen2 Myoelectric Hand - 8 1/4 RH QWD WhiteTASKA PROSTHETICS LIMITEDIQZ2026-01-07
09421906785043TASKA HandGen2 Myoelectric Hand - 8 1/4 RH QWD BlackTASKA PROSTHETICS LIMITEDIQZ2026-01-07
09421906785050TASKA HandGen2 Myoelectric Hand - 8 1/4 RH QWD SandTASKA PROSTHETICS LIMITEDIQZ2026-01-07
09421906785067TASKA HandGen2 Myoelectric Hand - 8 1/4 LH LP WhiteTASKA PROSTHETICS LIMITEDIQZ2026-01-07
09421906785074TASKA HandGen2 Myoelectric Hand - 8 1/4 LH LP BlackTASKA PROSTHETICS LIMITEDIQZ2026-01-07