AccessGUDID - DEVICE: ImPACT Pediatric (00864127000318)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 00864127000318
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 805665101 *Terms of Use

Device Description: ImPACT Pediatric is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion. ImPACT Pediatric is a neurocognitive test battery that provides healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 5-11.

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):	Yes
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?
30895	Cause-and-effect assistive training device	A device designed to be used to assist a person with a disability with developing an understanding of cause and effect (i.e., what is the reason for something to happen and what will be the outcome should it happen).	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 [?]
DEN150037	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: 870edfdd-64dc-4ea7-9119-1299d54c45aa
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: November 29, 2016