AccessGUDID - DEVICE: Zn-Air Battery Pak (07630016817977)

GUDID

Device Identifier (DI) Information

Brand Name: Zn-Air Battery Pak
Version or Model: CI-5500-220
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Advanced Bionics, LLC

Primary DI Number: 07630016817977
Issuing Agency: GS1
Commercial Distribution End Date: March 28, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 803906382 *Terms of Use

Device Description: Princess Pink

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
MCM	IMPLANT, COCHLEAR

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P960058	102

Device Exempt from Premarket Submission: No 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
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Temperature: between -20 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 84c4336e-e53d-4a94-bac4-f4f938ea2eb5
Public Version Date: March 28, 2024
Public Version Number: 5
DI Record Publish Date: October 24, 2015