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
00811204030096
GS1

1
061455809 *Terms of Use
Contains Charger (00811204030157) and two battery assemblies for ZPower Rechargeable System for Hearing Aids
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

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?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
ESD Hearing Aid, Air Conduction
OSM Hearing Aid, Air Conduction With Wireless Technology
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
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
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Cell Size 312
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Device Record Status

6d4ef6bd-825f-4922-9eb9-5fd13fc81c46
February 06, 2020
2
May 14, 2018
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
866-364-2909
support@zpowerbattery.com
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