hi Health Innovations 93237-000

GUDID 00858177007083

Hearing Aid Enhanced Audio Device

INTRICON CORPORATION

Hearing aid enhanced audio device, telecommunication/multimedia
Primary Device ID00858177007083
NIH Device Record Key13f02d14-91a1-4ec4-829c-20816d41a9b5
Commercial Distribution StatusIn Commercial Distribution
Brand Namehi Health Innovations
Version Model NumberCM1
Catalog Number93237-000
Company DUNS002345767
Company NameINTRICON CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone651-636-9770
Emailudi@intricon.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100858177007083 [Primary]

FDA Product Code

OSMHearing Aid, Air Conduction With Wireless Technology

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-11-14

On-Brand Devices [hi Health Innovations]

00858177007151hi-PS (Programming Software) Fitting Software, Solo
00858177007083Hearing Aid Enhanced Audio Device
00858177007076Hearing Aid Fitting Software
00858177007069Remote Control App
00858177007052Wireless Hearing Aid -001, Metallic Gray -002, Metallic Gold

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.