Aurix Software

GUDID 00627908090027

Aurix software for use with the Aurix system (DI: 00627908080011) The UDI for software 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

Evoked-potential audiometer

• Primary Device ID: 00627908090027
• NIH Device Record Key: 3b4f1511-457f-4f8a-acdb-1f7f90fb8321
• Commercial Distribution Discontinuation: 2020-04-20
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Aurix Software
• Version Model Number: SWA002
• 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: false
• Manufacturing Date: false
• 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	00627908090027 [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 Software ]

• 00062790890025: Aurix software for use with the Aurix system (DI: 00062790880019) The UDI for software is comp
• 00627908090027: Aurix software for use with the Aurix system (DI: 00627908080011) The UDI for software is comp