BrainCheck Assess

GUDID 00860011154501

BrainCheck Assess is a digital cognitive assessment platform.

Braincheck, Inc.

Cognitive assessment software

• Primary Device ID: 00860011154501
• NIH Device Record Key: 447a4690-e7bc-421e-a690-f16961184fea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BrainCheck Assess
• Version Model Number: 2
• Company DUNS: 079573092
• Company Name: Braincheck, Inc.
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860011154501 [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: 2023-12-25
• Device Publish Date: 2023-12-15