VivoTab Electrode (3 pack)

GUDID 00627908070050

Electrodes for use with the Integrity and Aurix system (DI: 00627908020017 and 00627908080011respectively). The UDI is comprised of the following: GTIN (01) + EXPIRY (17) + BATCH/LOT (10)

Vivosonic Inc

Evoked-potential audiometer

• Primary Device ID: 00627908070050
• NIH Device Record Key: 78efa17e-ee53-44a3-88a3-640a850caa6d
• Commercial Distribution Discontinuation: 2020-04-20
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: VivoTab Electrode (3 pack)
• Version Model Number: 100001
• 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	00627908070050 [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: 2017-10-05

On-Brand Devices [VivoTab Electrode (3 pack) ]

• 00062790870058: Electrodes for use with the Integrity and Aurix system (DI: 00062790820015 and 00062790880019
• 00627908070050: Electrodes for use with the Integrity and Aurix system (DI: 00627908020017 and 00627908080011r