Integrity Software

GUDID 00627908090010

Integrity software for use with the first generation Integrity V500 system (DI: 00627908010018) and the second generation of the Integrity V500 system (DI: 00627908020017). The UDI is comprised of the following: GTIN + Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) (which represents the software version) UDI Application Identifier for Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) = 240

Vivosonic Inc

Otoacoustic emission system, battery-powered
Primary Device ID00627908090010
NIH Device Record Key8f9d5de9-f4b4-462f-b011-a5cfa2e40b40
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntegrity Software
Version Model NumberSWA001
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 Numberfalse
Manufacturing Datefalse
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
GS100627908090010 [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 Number4
Public Version Date2020-04-21
Device Publish Date2016-09-23

On-Brand Devices [Integrity Software]

00062790890018Integrity software for use with the first generation Integrity V500 system (DI: 00062790810016)
00627908090010Integrity software for use with the first generation Integrity V500 system (DI: 00627908010018)

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