AccessGUDID - DEVICE: ImPACT Quick Test (00864127000356)

GUDID

Device Identifier (DI) Information

Brand Name: ImPACT Quick Test
Version or Model: 2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: IMPACT APPLICATIONS, INC.

Primary DI Number: 00864127000356
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 805665101 *Terms of Use

Device Description: ImPACT Quick Test is intended for use as a computerized cognitive test to aid in the assessment of concussion in individuals ages 12-70

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
63185	Cognitive assessment software	A software program intended to be used to assess cognitive function (e.g., attention/concentration, memory) and/or to assist early detection/diagnosis of mild cognitive impairment or dementia, using cognitive tests in combination with patient demographic data. The tests are completed by the patient on an off-the-shelf computer/tablet/smartphone and test results are intended to be reviewed by a medical specialist and/or used for longitudinal analysis. It is not intended for real-time home-monitoring of dementia patients.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
POM	Computerized Cognitive Assessment Aid For Concussion

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K170551	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 378f1939-5acb-4e04-aeef-36825ddbf555
Public Version Date: March 15, 2021
Public Version Number: 1
DI Record Publish Date: March 05, 2021