CNS Vital Signs Cognitrax

GUDID 00860013886134

CNS Vital Signs cognitive testing web platform. A limited set of cognitive tests and clinical questionnaires with audio instructions that can be administered in office.

CNS Vital Signs, LLC

Psychological assessment software

• Primary Device ID: 00860013886134
• NIH Device Record Key: 89b835c5-c43b-4988-b7ca-2bfc7fc4ae12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CNS Vital Signs Cognitrax
• Version Model Number: 1.1.4
• Company DUNS: 153552802
• Company Name: CNS Vital Signs, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860013886134 [Primary]

FDA Product Code

• PTY: Computerized Cognitive Assessment Aid, Exempt

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: 2025-07-15
• Device Publish Date: 2025-07-07

Devices Manufactured by CNS Vital Signs, LLC

• 00860013886127 - CNS Vital Signs VSC: 2025-09-09 CNS Vital Signs cognitive testing installed locally on iOS platform. A set of Cognitive tests and clinical questionaires that ca
• 00860013886103 - CNS Vital Signs Web: 2025-07-15 CNS Vital Signs cognitive testing web platform. A set of cognitive tests and clinical questionnaire that can be administered in
• 00860013886110 - CNS Vital Signs Local: 2025-07-15 CNS Vital Signs cognitive testing installed local software platform. A set of cognitive tests and clinical questionnaires admin
• 00860013886134 - CNS Vital Signs Cognitrax: 2025-07-15CNS Vital Signs cognitive testing web platform. A limited set of cognitive tests and clinical questionnaires with audio instructions that can be administered in office.
• 00860013886134 - CNS Vital Signs Cognitrax: 2025-07-15 CNS Vital Signs cognitive testing web platform. A limited set of cognitive tests and clinical questionnaires with audio instruct