Integrity V500

GUDID 00062790820015

Main handheld VivoLink unit for use with second generation Integrity V500 system. The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL) The following are accessories that may be used with the second generation Integrity V500 system: A81 Amplitrode: DI 00062790820022 A82 Amplitrode: DI 00062790820039 A90 VivoAmp: DI 00062790820046 B71W Bone Conductor: DI 00062790820053 ER-2-800 Insert Earphones: DI 00062790820060 ER-3A-800 Insert Earphones: DI 00062790820077 ER-3C-800 Insert Earphones: DI 00062790820084 H-800 EP Headphones: DI 00062790820091 H-801 EP Headphones: DI 00062790820107 P81-GP OAE Probe: DI 00062790820114 P81-UG OAE Probe: DI 00062790820121 Computer: DI 00062790820138

Vivosonic Inc

Otoacoustic emission system, battery-powered
Primary Device ID00062790820015
NIH Device Record Key7cfb0431-4736-42ba-b316-0019cc9acd04
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntegrity V500
Version Model NumberV500
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
GS100062790820015 [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 V500 ]

00062790820015Main handheld VivoLink unit for use with second generation Integrity V500 system. The UDI is com
00062790810016Main handheld VivoLink unit for use with the first generation Integrity V500 system. The UDI is
00627908020017Main handheld VivoLink unit for use with second generation Integrity V500 system. The UDI is com
00627908010018Main handheld VivoLink unit for use with the first generation Integrity V500 system. The UDI is

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