VivoTab Electrode (4 pack)

GUDID 00062790870065

Electrodes for use with the Integrity system (DI: 00062790820015). The UDI is comprised of the following: GTIN (01) + EXPIRY (17) + BATCH/LOT (10)

Vivosonic Inc

Evoked-potential audiometer

• Primary Device ID: 00062790870065
• NIH Device Record Key: c6c74f0d-166c-4e54-b47c-ab5256912dc3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VivoTab Electrode (4 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00062790870065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043396

FDA Product Code

• GWJ: Stimulator, Auditory, Evoked Response

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-06
• Device Publish Date: 2019-10-29

On-Brand Devices [VivoTab Electrode (4 pack) ]

• 00062790870065: Electrodes for use with the Integrity system (DI: 00062790820015). The UDI is comprised of the
• 00627908070067: Electrodes for use with the Integrity system (DI: 00627908020017). The UDI is comprised of the