AccessGUDID - DEVICE: Audioscan (B161RM500SL0)

GUDID

Device Identifier (DI) Information

Brand Name: Audioscan
Version or Model: RM500SL
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Etymonic Design Incorporated

Primary DI Number: B161RM500SL0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 244780581 *Terms of Use

Device Description: The RM500SL is a portable hearing aid analyzer intended to be used by hearing care professionals such as audiologists and hearing aid specialists to verify the electro-acoustic performance of a hearing aid connected to a standard earphone coupler or while worn on the ear of the end user.

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?
45241	Audiometric/hearing aid tester	An electroacoustic device intended to be used for both the evaluation of hearing loss (audiometer function) and the evaluation of hearing aids while worn for optimal amplification [real-ear measurement (REM)]; some types may in addition be used to test hearing aid function when being fitted to the patient. It typically consists of a test box and a control unit that connect to an off-the-shelf computer that runs application software to provide results and graphics (which may be stored in a database). It may be used as an audiometer or real-ear-measurement instrument without the test box.	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
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 15 and 30 Degrees Celsius
Handling Environment Humidity: between 20 and 50 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 81 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7a544816-4d15-4362-895f-1fdc220f0af5
Public Version Date: November 17, 2023
Public Version Number: 3
DI Record Publish Date: September 23, 2016