contact mini 77734112

GUDID 09120041050213

contact mini, monaural, black; bone-conduction hearing system

BHM-Tech Produktionsgesellschaft m.b.H.

Head-worn bone-conduction hearing aid
Primary Device ID09120041050213
NIH Device Record Key9c1fd50d-90a7-4410-a85e-b8bea253aa13
Commercial Distribution StatusIn Commercial Distribution
Brand Namecontact mini
Version Model NumberCONTACT-MINI/MON/SW
Catalog Number77734112
Company DUNS300632705
Company NameBHM-Tech Produktionsgesellschaft m.b.H.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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

Phone+43335920078
Emailnice_2_hear_u@bhm-tech.at

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS109120041050213 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXBHearing Aid, Bone Conduction

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-04-06
Device Publish Date2016-09-20

On-Brand Devices [contact mini]

09120041050213contact mini, monaural, black; bone-conduction hearing system
09120041050206contact mini, monaural, red; bone-conduction hearing system
09120041050183contact mini, monaural, blue; bone-conduction hearing system
09120041050169contact mini, binaural, black; bone-conduction hearing system
09120041050152contact mini, binaural, red; bone-conduction hearing system
09120041050138contact mini, binaural, blue; bone-conduction hearing system

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