Aurix Newborn Hearing Screening System

GUDID 00627908080011

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: 00627908080028 11003 Amplifier DI: 00627908080035 11010 Laptop Computer DI: 00627908080042 100116 Amplifier Lead Cable DI: 00627908080059 ER-3A-AUX Insert Earphones DI:00627908080066 100001 Electrodes DI: 00627908070067 100004 Ear Domes DI: 00627908080080 WA021 Tablet Computer DI: 00627908080097

Vivosonic Inc

Evoked-potential audiometer

• Primary Device ID: 00627908080011
• NIH Device Record Key: decbcb6b-0530-4b07-8e54-1e31c472ae6f
• Commercial Distribution Discontinuation: 2020-04-20
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Aurix Newborn Hearing Screening System
• Version Model Number: AURIX-1
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	00627908080011 [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 Newborn Hearing Screening System ]

• 00062790880019: Main handheld unit for use with the Aurix system. The UDI is comprised of: GTIN + version/rev
• 00627908080011: Main handheld unit for use with the Aurix system. The UDI is comprised of: GTIN + version/rev