FDA.reportPublic FDA data

Integrity V500

Primary DI
00627908020017
Brand
Integrity V500
Company
Vivosonic Inc
Model
V500
Device description
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 00627908020024A82 Amplitrode: DI 00627908020031A90 VivoAmp: DI 00627908020048B71W Bone Conductor: DI 00627908020055ER-2-800 Insert Earphones: DI 00627908020062ER-3A-800 Insert Earphones: DI 00627908020079ER-3C-800 Insert Earphones: DI 00627908020086H-800 EP Headphones: DI 00627908020093H-801 EP Headphones: DI 00627908020109P81-GP OAE Probe: DI 00627908020116P81-UG OAE Probe: DI 00627908020123Computer: DI 00627908020130
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EWOAudiometer
GWJStimulator, Auditory, Evoked Response

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EWOAudiometerEar, Nose, Throat2
GWJStimulator, Auditory, Evoked ResponseNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K043396000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043396000INTEGRITY, MODEL V500Vivosonic, Inc.2005-01-24GWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00627908020017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00627908020017006279080200176279080200170627908020017

GMDN Terms#

Term, Definition table
TermDefinition
Otoacoustic emission system, battery-poweredAn assembly of battery-powered devices designed to record and analyse the faint sounds hair cells in the inner ear emit [otoacoustic emission (OAE)] in response to a stimulus (e.g., click, tone burst, pure-tone signals) to test for a deficiency of function in the ear during diagnostic evaluation and/or neonatal screening. It typically consists of a portable programmable unit, an OAE probe, and eartips. The stimulus signal is emitted via the probe inserted into the ear canal and the response is recorded via a microphone in the probe; OAEs are absent/reduced in patients with hearing loss. The system may be combined with other audiological devices (e.g., tympanometer, ABR device).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
201740425
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00627908020192Bone ConductorB812023-06-12
00627908020178EP HeadphonesH-8022023-06-08
00627908020185ECochG AdaptersE-1102023-06-08
00627908020154Integrity VivoStimST-8002020-05-04
00627908010018Integrity V500V5002016-09-23
00627908010025Integrity Amplitrode A61 2016-09-23
00627908010032Integrity Bone Conductor B71-102016-09-23
00627908010049Integrity Insert Earphones ER-3A-ABR2016-09-23
00627908010056Integrity EP Headphones HDA 300 2016-09-23
00627908010063Integrity OAE Probe P40-GP2016-09-23
00627908010070Integrity OAE Probe P40-UG2016-09-23
00627908020024Integrity Amplitrode A81 2016-09-23
00627908020031Integrity Amplitrode A82 2016-09-23
00627908020048Integrity VivoAmpA902016-09-23
00627908020055Integrity Bone Conductor B71W2016-09-23
00627908020062Integrity Insert Earphones ER-2-8002016-09-23
00627908020079Integrity Insert Earphones ER-3A-8002016-09-23
00627908020086Integrity Insert Earphones ER-3C-8002016-09-23
00627908020093Integrity EP Headphones H-8002016-09-23
00627908020109Integrity EP Headphones H-8012016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260223145995Ear Coupler SetPATH medical GmbHGWJ2026-07-24
04260223147579Infant Insert Eartips 4.0mm (bag of 20)PATH medical GmbHEWO2026-07-24
04260223147579Infant Insert Eartips 4.0mm (bag of 20)PATH medical GmbHGWJ2026-07-24
04260223147586Infant Insert Eartips 3.5mm (bag of 20)PATH medical GmbHEWO2026-07-24
04260223147586Infant Insert Eartips 3.5mm (bag of 20)PATH medical GmbHGWJ2026-07-24
04260223147654Bone Conductor BC-2LDPATH medical GmbHEWO2026-07-24
04260223147654Bone Conductor BC-2LDPATH medical GmbHGWJ2026-07-24
04260223147661Bone Conductor BC-2LDPATH medical GmbHEWO2026-07-24
04260223147661Bone Conductor BC-2LDPATH medical GmbHGWJ2026-07-24
04260223147678Bone Conductor BC-2LDPATH medical GmbHEWO2026-07-24
04260223147678Bone Conductor BC-2LDPATH medical GmbHGWJ2026-07-24
04260223147746Ear Coupler TRPATH medical GmbHGWJ2026-07-24
04260223147975PIEP (2x2)PATH medical GmbHEWO2026-07-24
04260223147975PIEP (2x2)PATH medical GmbHGWJ2026-07-24
04260223148002Accessory box AB-LT02PATH medical GmbHGWJ2026-07-24
05713315006890Madsen AccsucreenNatus Medical Denmark ApSGWJ2026-07-08
05713315006906Madsen AccuscreenNatus Medical Denmark ApSGWJ2026-07-08
00860016073401Evoke EEG SystemFirefly Neuroscience, Inc.GWJ2026-07-07
00860016073418Evoke EEG System AmplifierFirefly Neuroscience, Inc.GWJ2026-07-07
057133150000581052 OTOsuiteNatus Medical Denmark ApSEWO2026-06-22
057133150007511066 OTOsuiteNatus Medical Denmark ApSEWO2026-06-22
057133150007681052 OTOsuiteNatus Medical Denmark ApSEWO2026-06-22
00817020020723Screener CartINTELLIGENT HEARING SYSTEMS CORP.GWJ2026-06-10
00817020020723Screener CartINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020020990Trigger Out Cable for USB Jr DuetINTELLIGENT HEARING SYSTEMS CORP.GWJ2026-06-10
00817020021027Toy Cabinet (Small)INTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021034Bone Vibrator w/Cable and Headband (B71)INTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021089DD45-300 Headphones with Pediatric HeadbandINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021096DD45-300 Headphones with Easy Adjust HeadbandINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021133OAE Probe OP23INTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10