Integrity VivoAmp

GUDID 00062790820046

Dual channel VivoAmp for use as an accessory with the second generation Integrity V500 system (DI: 00062790820015) The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)

Vivosonic Inc

Evoked-potential audiometer
Primary Device ID00062790820046
NIH Device Record Keyc0a71dcd-1360-4472-aefb-1a04f0254d0d
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntegrity VivoAmp
Version Model NumberA90
Company DUNS201740425
Company NameVivosonic Inc
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100062790820046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EWOAudiometer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

On-Brand Devices [Integrity VivoAmp]

00062790820046Dual channel VivoAmp for use as an accessory with the second generation Integrity V500 system (D
00627908020048Dual channel VivoAmp for use as an accessory with the second generation Integrity V500 system (D

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