AccessGUDID - DEVICE: audifon (EADF034106002172068681)

GUDID

Device Identifier (DI) Information

Brand Name: audifon
Version or Model: audifon APP 1.4.2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 03410600217206868
Company Name: audifon GmbH & Co. KG

Primary DI Number: EADF034106002172068681
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 344064407 *Terms of Use

Device Description: audifon APP

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):	Yes
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?
57884	Hearing aid wireless-fitting computer-aided set	A collection of devices designed to work in conjunction with a computer to transmit wireless data to a hearing aid for computer-aided adjustment of the hearing aid while it is being fitted to a patient by healthcare personnel. It primarily consists of computer application software and a neck loop to establish the wireless link (the radio link protocol) with the hearing aid. The hearing aid must be compatible for wireless data reception and may be behind-the-ear (BTE), in-the-ear (ITE) and completely-in-the-canal (CIC) types.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ETW	Calibrator, Hearing Aid / Earphone And Analysis Systems

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f61f1a19-51d5-49c7-80a9-7c244ae9edfa
Public Version Date: October 31, 2022
Public Version Number: 1
DI Record Publish Date: October 21, 2022