Aurix Ear Domes

GUDID 00627908080080

Ear domes for use with the Aurix system (DI: 00627908080011) The UDI is comprised of the following: GTIN (01) + EXPIRY (17) + BATCH/LOT (10)

Vivosonic Inc

Evoked-potential audiometer

• Primary Device ID: 00627908080080
• NIH Device Record Key: f6e18452-03f9-49ec-bf50-f797c8527b66
• Commercial Distribution Discontinuation: 2020-04-20
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Aurix Ear Domes
• Version Model Number: 100004
• Company DUNS: 201740425
• Company Name: Vivosonic Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00627908080080 [Primary]

FDA Product Code

• GWJ: Stimulator, Auditory, Evoked Response

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-04-21
• Device Publish Date: 2016-09-23

On-Brand Devices [Aurix Ear Domes ]

• 00062790880088: Ear domes for use with the Aurix system (DI: 00062790880019) The UDI is comprised of the follo
• 00627908080080: Ear domes for use with the Aurix system (DI: 00627908080011) The UDI is comprised of the follo