DEVICE: ImPACT Pediatric (00864127000318)
Device Identifier (DI) Information
ImPACT Pediatric
ImPACT Pediatric
In Commercial Distribution
IMPACT APPLICATIONS, INC.
ImPACT Pediatric
In Commercial Distribution
IMPACT APPLICATIONS, INC.
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
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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).
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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POM | Computerized Cognitive Assessment Aid For Concussion |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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DEN150037 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
870edfdd-64dc-4ea7-9119-1299d54c45aa
July 06, 2018
3
November 29, 2016
July 06, 2018
3
November 29, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
877.646.7991
support@impacttest.com
support@impacttest.com