DEVICE: ImPACT Pediatric (00864127000318)

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Device Identifier (DI) Information

ImPACT Pediatric
ImPACT Pediatric

IMPACT APPLICATIONS, INC.
00864127000318
GS1
1
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

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

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
November 29, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
No
No
No
No CLOSE

Customer Contact

[?]
877.646.7991
support@impacttest.com
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