| Primary Device ID | 00864127000332 |
| NIH Device Record Key | ccddb308-3642-4e52-be32-1d0518d01e58 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cognitive Impairment Screener |
| Version Model Number | 1 |
| Company DUNS | 805665101 |
| Company Name | IMPACT APPLICATIONS, 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00864127000332 [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 | 2020-12-24 |
| Device Publish Date | 2020-12-16 |
| 00864127000356 - ImPACT Quick Test | 2021-03-15 ImPACT Quick Test is intended for use as a computerized cognitive test to aid in the assessment of concussion in individuals age |
| 00864127000349 - ImPACT Version 4 | 2021-03-08 ImPACT is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion |
| 00864127000332 - Cognitive Impairment Screener | 2020-12-24 |
| 00864127000332 - Cognitive Impairment Screener | 2020-12-24 |
| 00864127000301 - ImPACT | 2018-07-06 ImPACT is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion |
| 00864127000318 - ImPACT Pediatric | 2018-07-06 ImPACT Pediatric is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of |
| 00864127000325 - ImPACT Quick Test | 2018-07-06 ImPACT Quick Test is intended for use as a computerized cognitive test to aid in the assessment of concussion in individuals age |