DEVICE: ZPower Rechargeable System for Hearing Aids (00811204030096)
Device Identifier (DI) Information
ZPower Rechargeable System for Hearing Aids
Z502-312
In Commercial Distribution
9-06-00142-05
ZPOWER, LLC
Z502-312
In Commercial Distribution
9-06-00142-05
ZPOWER, LLC
Contains Charger (00811204030157) and two battery assemblies for ZPower Rechargeable System for Hearing Aids
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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17115 | Noninvasive device battery charger |
An 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ESD | Hearing Aid, Air Conduction |
OSM | Hearing Aid, Air Conduction With Wireless Technology |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Atmospheric Pressure: more than 11 KiloPascal |
Handling Environment Humidity: between 20 and 75 Percent (%) Relative Humidity |
Handling Environment Temperature: between 50 and 104 Degrees Fahrenheit |
Storage Environment Temperature: between 14 and 122 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: Cell Size 312 |
Device Record Status
6d4ef6bd-825f-4922-9eb9-5fd13fc81c46
February 06, 2020
2
May 14, 2018
February 06, 2020
2
May 14, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
866-364-2909
support@zpowerbattery.com
support@zpowerbattery.com