FDA.reportPublic FDA data

Aurix Newborn Hearing Screening System

Primary DI
00627908080011
Brand
Aurix Newborn Hearing Screening System
Company
Vivosonic Inc
Model
AURIX-1
Device description
Main handheld unit for use with the Aurix system. The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)The following devices are accessories for use with the Aurix system: 11002 Sound Stimulator DI: 0062790808002811003 Amplifier DI: 0062790808003511010 Laptop Computer DI: 00627908080042100116 Amplifier Lead Cable DI: 00627908080059ER-3A-AUX Insert Earphones DI:00627908080066100001 Electrodes DI: 00627908070067100004 Ear Domes DI: 00627908080080WA021 Tablet Computer DI: 00627908080097
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GWJStimulator, Auditory, Evoked Response

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWJStimulator, Auditory, Evoked ResponseNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00627908080011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00627908080011006279080800116279080800110627908080011

GMDN Terms#

Term, Definition table
TermDefinition
Evoked-potential audiometerAn electroacoustic instrument designed to evaluate the activity of the auditory pathway of the brain in response to an acoustic signal [auditory brainstem response (ABR)] it provides at the ear (e.g., clicks delivered through an earphone), without need of patient cooperation. The signal, detected via the device's scalp electrodes and possibly a reference electrode on the ear lobe, is measured using computer averaging and signal processing techniques. This device is typically used to assess the function of the auditory pathways and to differentiate coma due to metabolic factors from structural damage.

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
00627908020017Integrity V500 V5002016-09-23
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

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Primary DI, Brand, Company table
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08056446901113NExT-PADEB NEURO SPAGWJ2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAGWJ2025-05-22
08056446901137NExT-HSEB NEURO SPAGWJ2025-05-22
08056446901168NExT-AMPEB NEURO SPAGWJ2025-05-22
08056446901199NExT-ASEB NEURO SPAGWJ2025-05-22
08056446901205NExT StationEB NEURO SPAGWJ2025-05-22
08056446901090NExT Station AdvancedEB NEURO SPAGWJ2025-05-19
00817020021126AriaINTELLIGENT HEARING SYSTEMS CORP.GWJ2024-03-11
00627908020178EP HeadphonesVivosonic IncGWJ2023-06-08
00627908020185ECochG AdaptersVivosonic IncGWJ2023-06-08
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyGWJ2023-04-19
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00195278466662E-EEGXGE Healthcare Finland OyGWJ2022-07-01
00195278466679N-EEGXGE Healthcare Finland OyGWJ2022-07-01
08056446900642Galileo NT Line SoftwareEB NEURO SPAGWJ2020-05-25
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00382830045315Echo-Screen III ProNATUS MEDICAL INCORPORATEDGWJ2020-02-20
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08056446900215NeMus PC PERIPHERALEB NEURO SPAGWJ2019-05-24
08056446900222NeMus 1EB NEURO SPAGWJ2019-05-24
08056446900239NeMus 1EB NEURO SPAGWJ2019-05-24