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 |