FDA.reportPublic FDA data

ZPower Rechargeable System for Hearing Aids

Primary DI
10850034007448
Brand
ZPower Rechargeable System for Hearing Aids
Company
ZPOWER, LLC
Model
Z602-312
Catalog number
9-05-00279-3
Device description
Charger for ZPower Rechargeable System for Hearing Aids
Published
2017-12-22
Public version status
Update
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
10850034007448PackageGS11In Commercial Distribution
00850034007441PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003400744810850034007448
00850034007441008500340074418500340074410850034007441

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive device battery chargerAn electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable.

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

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

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