Core Cognitive Evaluation 20001
GUDID B626200010
Core Cognitive Evaluation is a non-invasive test that assess possible cognitive impairment. It is intended to be used by medical professionals qualified to interpret results of a cognitive assessment.
Linus Health, Inc.
Cognitive assessment software| Primary Device ID | B626200010 |
| NIH Device Record Key | 8f900a25-8da5-43a8-8312-9f87963099d6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Core Cognitive Evaluation |
| Version Model Number | 20001 |
| Catalog Number | 20001 |
| 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 | true |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B626200010 [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 | 2022-07-06 |
| Device Publish Date | 2022-06-28 |
On-Brand Devices [Core Cognitive Evaluation ]
| B626200010 | Core Cognitive Evaluation is a non-invasive test that assess possible cognitive impairment. It i |
| B626200050 | 20005 |
Trademark Results [Core Cognitive Evaluation]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CORE COGNITIVE EVALUATION 97522115 not registered Live/Pending |
Linus Health, Inc. 2022-07-27 |
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