Integrity Computer

GUDID 00627908020130

Laptop computer for use with the first generation of the Integrity V500 system (DI: 00627908010018) and the second generation of the Integrity V500 system (DI: 00627908020017). The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)

Vivosonic Inc

Otoacoustic emission system, battery-powered

• Primary Device ID: 00627908020130
• NIH Device Record Key: 27a97f14-8f0d-4dfb-a8de-dddb316b02d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integrity Computer
• Version Model Number: M500-C
• 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	00627908020130 [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 Computer ]

• 00062790820138: Laptop computer for use with the first generation of the Integrity V500 system (DI: 00062790810
• 00627908020130: Laptop computer for use with the first generation of the Integrity V500 system (DI: 00627908010