AccessGUDID - DEVICE: AMPLIFON (00840388206744)

GUDID

Device Identifier (DI) Information

Brand Name: AMPLIFON
Version or Model: REMOTE MICROPHONE 2.0 |2.4 GH LE UNBRANDED ST
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Starkey Laboratories, Inc.

Primary DI Number: 00840388206744
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 055461479 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
57886	Hearing aid enhanced audio device, telecommunication/multimedia	A battery-powered device designed to provide high-definition digital wireless audio transmission from an external telecommunication audio source [e.g., television (TV), radio/stereo equipment, mobile phone (cell phone)] to a hearing aid, to enhance the sound quality received by the wearer of the hearing aid. It is typically a hand-held electronic unit, portable or placed in the home, intended to provide features such as artefact-free, echo-free, real-time audio transmission in and sometimes to remotely manage selected features in the hearing aid or external audio source for improved sound quality.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OSM	Hearing Aid, Air-Conduction with Wireless Technology, Prescription

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
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -40 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 98780145-3539-4b2b-815e-36ffd306dc11
Public Version Date: August 20, 2025
Public Version Number: 2
DI Record Publish Date: June 25, 2025