FDA.reportPublic FDA data

ZPower Rechargeable System for Hearing Aids

Primary DI
10811204030567
Brand
ZPower Rechargeable System for Hearing Aids
Company
ZPOWER, LLC
Model
Z701-312
Catalog number
9-05-00245-05
Device description
Battery Door Module for ZPower Rechargeable System for Hearing Aids
Published
2019-05-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10811204030567PackageGS11In Commercial Distribution
00811204030560PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081120403056710811204030567
00811204030560008112040305608112040305600811204030560

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
80850034007157ZPower Rechargeable System for Hearing AidsZ302-3129-06-00073-02017-12-31

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