| Primary Device ID | B626200020 |
| NIH Device Record Key | 1a2b2b22-26ea-4a8b-87ac-562d6b363799 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Research Platform |
| Version Model Number | 20002 |
| 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 Issuing Agency | Device ID |
|---|---|
| HIBCC | B626200020 [Primary] |
| PTY | Computerized Cognitive Assessment Aid, Exempt |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-09-12 |
| Device Publish Date | 2022-09-03 |
| B626200050 - Core Cognitive Evaluation | 2024-06-13 |
| B626200020 - Research Platform | 2022-09-12 |
| B626200020 - Research Platform | 2022-09-12 |
| B626200010 - Core Cognitive Evaluation | 2022-07-06 Core Cognitive Evaluation is a non-invasive test that assess possible cognitive impairment. It is intended to be used by medical |