Vemp Monitor

GUDID 05713315008795

Vemp Monitor, Chartr EP

Gn Otometrics A/S

Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator
Primary Device ID05713315008795
NIH Device Record Key5c04946f-0629-478e-affe-e0f446b61fe7
Commercial Distribution StatusIn Commercial Distribution
Brand NameVemp Monitor
Version Model Number8-36-00520
Company DUNS306633756
Company NameGn Otometrics A/S
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105713315008795 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWJStimulator, Auditory, Evoked Response

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-12
Device Publish Date2021-03-04

On-Brand Devices [Vemp Monitor]

05713315008801Vemp Monitor
05713315008795Vemp Monitor, Chartr EP

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