AccessGUDID - DEVICE: ZPower Rechargeable System for Hearing Aids (80850034007003)

GUDID

Device Identifier (DI) Information

Brand Name: ZPower Rechargeable System for Hearing Aids
Version or Model: Z101-312
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9-06-00048-1
Company Name: ZPOWER, LLC

Primary DI Number: 80850034007003
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 061455809 *Terms of Use

Device Description: Battery Door Module for ZPower Rechargeable System for Hearing Aids (Packaged Individually)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58185	Cochlear implant/auditory brainstem implant battery	An external component of a cochlear implant (CI) or auditory brainstem implant system designed to supply direct current (DC) to operate the electrically-powered and dependent components of the system. It is typically worn behind-the-ear (BTE), or is neck- or waist-worn, and may include an on/off switch. This is a reusable device.	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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Cell Size 312

Device Record Status

Public Device Record Key: 77d3b887-6938-4db4-a737-4dd217089fde
Public Version Date: April 08, 2022
Public Version Number: 3
DI Record Publish Date: December 31, 2017