Cognitive Impairment Screener

GUDID 00864127000332

IMPACT APPLICATIONS, INC.

Cognitive assessment software
Primary Device ID00864127000332
NIH Device Record Keyccddb308-3642-4e52-be32-1d0518d01e58
Commercial Distribution StatusIn Commercial Distribution
Brand NameCognitive Impairment Screener
Version Model Number1
Company DUNS805665101
Company NameIMPACT APPLICATIONS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100864127000332 [Primary]

FDA Product Code

PTYComputerized Cognitive Assessment Aid, Exempt

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-24
Device Publish Date2020-12-16

Devices Manufactured by IMPACT APPLICATIONS, INC.

00864127000356 - ImPACT Quick Test2021-03-15 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 42021-03-08 ImPACT is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion
00864127000332 - Cognitive Impairment Screener2020-12-24
00864127000332 - Cognitive Impairment Screener2020-12-24
00864127000301 - ImPACT2018-07-06 ImPACT is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion
00864127000318 - ImPACT Pediatric2018-07-06 ImPACT Pediatric is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of
00864127000325 - ImPACT Quick Test2018-07-06 ImPACT Quick Test is intended for use as a computerized cognitive test to aid in the assessment of concussion in individuals age

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