Cognivue Advanced Desktop

GUDID 00860000564014

COGNIVUE, INC.

Cognitive assessment software

• Primary Device ID: 00860000564014
• NIH Device Record Key: d6e96e0e-85a9-42d3-974d-c5e27f28e3bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cognivue Advanced Desktop
• Version Model Number: Desktop Unit
• Company DUNS: 115618437
• Company Name: COGNIVUE, 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: false
• 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

Customer Support Contacts

• Phone: 585-203-1969
• Email: support@cognivue.com
• Phone: 585-203-1969
• Email: support@cognivue.com
• Phone: 585-203-1969
• Email: support@cognivue.com
• Phone: 585-203-1969
• Email: support@cognivue.com
• Phone: 585-203-1969
• Email: support@cognivue.com
• Phone: 585-203-1969
• Email: support@cognivue.com
• Phone: 585-203-1969
• Email: support@cognivue.com
• Phone: 585-203-1969
• Email: support@cognivue.com
• Phone: 585-203-1969
• Email: support@cognivue.com
• Phone: 585-203-1969
• Email: support@cognivue.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860000564014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN130033

FDA Product Code

• PKQ: Computerized Cognitive Assessment Aid

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: 2020-04-20
• Device Publish Date: 2020-04-10

Devices Manufactured by COGNIVUE, INC.

• 00860000564045 - Cognivue Clarity: 2025-06-20
• 00860000564052 - Cognivue Thrive: 2025-06-20
• 00860000564007 - Cognivue Advanced with Cart: 2020-04-20
• 00860000564014 - Cognivue Advanced Desktop: 2020-04-20
• 00860000564014 - Cognivue Advanced Desktop: 2020-04-20
• 00860000564021 - Cognivue Clarity: 2020-04-20
• 00860000564038 - Cognivue Thrive: 2020-04-20