ImPACT Pediatric

GUDID 00864127000318

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.

IMPACT APPLICATIONS, INC.

Cause-and-effect assistive training device

• Primary Device ID: 00864127000318
• NIH Device Record Key: 870edfdd-64dc-4ea7-9119-1299d54c45aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ImPACT Pediatric
• Version Model Number: ImPACT Pediatric
• Company DUNS: 805665101
• Company Name: IMPACT APPLICATIONS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 877.646.7991
• Email: support@impacttest.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00864127000318 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN150037

FDA Product Code

• POM: Computerized Cognitive Assessment Aid For Concussion

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-29

Devices Manufactured by IMPACT APPLICATIONS, INC.

• 00864127000356 - ImPACT Quick Test: 2021-03-15 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 4: 2021-03-08 ImPACT is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion
• 00864127000332 - Cognitive Impairment Screener: 2020-12-24
• 00864127000301 - ImPACT: 2018-07-06 ImPACT is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion
• 00864127000318 - ImPACT Pediatric: 2018-07-06ImPACT 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.
• 00864127000318 - ImPACT Pediatric: 2018-07-06 ImPACT Pediatric is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of
• 00864127000325 - ImPACT Quick Test: 2018-07-06 ImPACT Quick Test is intended for use as a computerized cognitive test to aid in the assessment of concussion in individuals age