Integrity CV-Amp

GUDID 00062790820145

Dual channel CV-Amp for use as an accessory with the second generation Integrity V500 system (DI: 00062790820015) The UDI is comprised of GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)

Vivosonic Inc

Evoked-potential audiometer

• Primary Device ID: 00062790820145
• NIH Device Record Key: 4106a2c5-5f54-41d7-9ec4-487bfb1b57c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integrity CV-Amp
• Version Model Number: A91
• 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	00062790820145 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043396

FDA Product Code

• EWO: Audiometer

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: 2019-03-28
• Device Publish Date: 2019-03-20

On-Brand Devices [Integrity CV-Amp]

• 00627908020147: Dual channel CV-Amp for use as an accessory with the second generation Integrity V500 system (DI
• 00062790820145: Dual channel CV-Amp for use as an accessory with the second generation Integrity V500 system (DI