Integrity V500

GUDID 00627908020017

Main handheld VivoLink unit for use with second generation Integrity V500 system. The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL) The following are accessories that may be used with the second generation Integrity V500 system: A81 Amplitrode: DI 00627908020024 A82 Amplitrode: DI 00627908020031 A90 VivoAmp: DI 00627908020048 B71W Bone Conductor: DI 00627908020055 ER-2-800 Insert Earphones: DI 00627908020062 ER-3A-800 Insert Earphones: DI 00627908020079 ER-3C-800 Insert Earphones: DI 00627908020086 H-800 EP Headphones: DI 00627908020093 H-801 EP Headphones: DI 00627908020109 P81-GP OAE Probe: DI 00627908020116 P81-UG OAE Probe: DI 00627908020123 Computer: DI 00627908020130

Vivosonic Inc

Otoacoustic emission system, battery-powered

• Primary Device ID: 00627908020017
• NIH Device Record Key: 7cfb0431-4736-42ba-b316-0019cc9acd04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integrity V500
• Version Model Number: V500
• 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	00627908020017 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-04-21
• Device Publish Date: 2016-09-23

On-Brand Devices [Integrity V500 ]

• 00062790820015: Main handheld VivoLink unit for use with second generation Integrity V500 system. The UDI is com
• 00062790810016: Main handheld VivoLink unit for use with the first generation Integrity V500 system. The UDI is
• 00627908020017: Main handheld VivoLink unit for use with second generation Integrity V500 system. The UDI is com
• 00627908010018: Main handheld VivoLink unit for use with the first generation Integrity V500 system. The UDI is