Core Cognitive Evaluation 20005

GUDID B626200050

Linus Health, Inc.

Cognitive assessment software

• Primary Device ID: B626200050
• NIH Device Record Key: 3817a706-98c7-4268-b762-95d24593e342
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Core Cognitive Evaluation
• Version Model Number: 20005
• Catalog Number: 20005
• Company DUNS: 117137874
• Company Name: Linus Health, 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: true
• Serial Number: false
• Manufacturing Date: true
• 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
HIBCC	B626200050 [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: 2024-06-13
• Device Publish Date: 2024-06-05

On-Brand Devices [Core Cognitive Evaluation]

• B626200010: Core Cognitive Evaluation is a non-invasive test that assess possible cognitive impairment. It i
• B626200050: 20005