AccessGUDID - DEVICE: Hearing Help Express (00858177007113)

GUDID

Device Identifier (DI) Information

Brand Name: Hearing Help Express
Version or Model: HHE Hearing
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 23150
Company Name: INTRICON CORPORATION

Primary DI Number: 00858177007113
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002345767 *Terms of Use

Device Description: iOS 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?
60211	Audiometric/hearing device software	A software program intended to assist with the evaluation of a patient’s hearing capability and/or evaluate and adjust the settings of a hearing assistive device. It may be used by healthcare professionals in a healthcare facility or by the patient in the home, and intended to be used on a non-medical computerized device (e.g., smartphone, tablet).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 87edee90-24cc-47e7-b118-5e1323d28524
Public Version Date: November 03, 2023
Public Version Number: 3
DI Record Publish Date: February 25, 2019