Aurix Newborn Hearing Screening System

Basic Information

• Brand Name: Aurix Newborn Hearing Screening System
• Primary DI: 00627908080011
• Version / Model: AURIX-1
• Company Name: Vivosonic Inc
• Labeler DUNS: 201740425
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2020-04-21
• Public Version Status: Update
• Public Device Record Key: decbcb6b-0530-4b07-8e54-1e31c472ae6f
• Distribution End Date: 2020-04-20

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: 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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GWJ	Stimulator, Auditory, Evoked Response	Neurology	882.1900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35747	Evoked-potential audiometer	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00627908080011	GS1