FDA.reportPublic FDA data

ZPower Rechargeable System for Hearing Aids

Primary DI
80850034007157
Brand
ZPower Rechargeable System for Hearing Aids
Company
ZPOWER, LLC
Model
Z302-312
Catalog number
9-06-00073-0
Device description
Battery Door Module for ZPower Rechargeable System for Hearing Aids (Packaged Individually)
Published
2017-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
ESDHearing Aid, Air Conduction
OSMHearing Aid, Air Conduction With Wireless Technology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ESDHearing Aid, Air-Conduction, PrescriptionEar, Nose, Throat1
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
80850034007157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
8085003400715780850034007157

GMDN Terms#

Term, Definition table
TermDefinition
Cochlear implant system battery packThe non-sterile external portion of a cochlear implant system [cochlear implant (CI)] that typically consists of a holder or container designed to hold batteries that supply direct current (DC) to all of the electrically-powered/dependent components of the CI. It is typically worn behind-the-ear (BTE) and may include an on/off switch. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure11 KiloPascal0 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Temperature14 Degrees Fahrenheit122 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-364-2909support@zpowerbattery.com

Regulatory Flags#

DUNS number
061455809
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811204030539ZPower Rechargeable System for Hearing AidsZ701-3129-05-00245-022019-05-01
00811204030546ZPower Rechargeable System for Hearing AidsZ701-3129-05-00245-032019-05-01
00811204030553ZPower Rechargeable System for Hearing AidsZ701-3129-05-00245-042019-05-01
00811204030560ZPower Rechargeable System for Hearing AidsZ701-3129-05-00245-052019-05-01
00850034007434ZPower Rechargeable System for Hearing AidsZ602-3129-05-00267-012017-12-22
00850034007496ZPower Rechargeable System for Hearing AidsZ701-3129-05-00245-012017-12-22
00850034007656ZPower Rechargeable System for Hearing AidsZ602-3129-05-00267-022017-12-22
00850034007663ZPower Rechargeable System for Hearing AidsZ602-3129-05-00267-032017-12-22
00811204030591ZPower Rechargeable System for Hearing AidsZ701-3129-06-00162-01-NA2019-11-08
00811204030621ZPower Rechargeable System for Hearing AidsZ701-3129-06-00162-02-NA2019-11-08
00811204030652ZPower Rechargeable System for Hearing AidsZ701-3129-06-00162-03-NA2019-11-08
00811204030683ZPower Rechargeable System for Hearing AidsZ701-3129-06-00162-04-NA2019-11-08
00811204030713ZPower Rechargeable System for Hearing AidsZ701-3129-06-00162-05-NA2019-11-08
00811204030287ZPower Rechargeable System for Hearing AidsZ701-3129-06-00109-02-NA2019-05-01
00811204030331ZPower Rechargeable System for Hearing AidsZ701-3129-06-00109-03-NA2019-05-01
00811204030386ZPower Rechargeable System for Hearing AidsZ701-3129-06-00109-04-NA2019-05-01
00811204030430ZPower Rechargeable System for Hearing AidsZ701-3129-06-00109-05-NA2019-05-01
80850034007003ZPower Rechargeable System for Hearing AidsZ101-3129-06-00048-12017-12-31
80850034007072ZPower Rechargeable System for Hearing AidsZ202-3129-06-00071-62017-12-31
80850034007195ZPower Rechargeable System for Hearing AidsZ304-3129-06-00074-22017-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05708296253166GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253173GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253180GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253197GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253203GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253210GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253227GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253234GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253241GN ReSoundGn Hearing A/SOSM2026-09-21
05708296257966GN ReSoundGn Hearing A/SOSM2026-09-21
05708296257973GN ReSoundGn Hearing A/SOSM2026-09-21
05708296257980GN ReSoundGn Hearing A/SOSM2026-09-21
05708296257997GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258000GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258017GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258024GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258031GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258048GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258321GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258338GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258345GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258352GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258369GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258376GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258383GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258390GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258406GN ReSoundGn Hearing A/SOSM2026-09-21
05708296434602GN HearingGn Hearing A/SOSM2026-09-21
05708296434770GN HearingGn Hearing A/SOSM2026-09-21
05708296434794GN HearingGn Hearing A/SOSM2026-09-21