Cognitive Impairment Screener

GUDID 00864127000332

IMPACT APPLICATIONS, INC.

Cognitive assessment software Cognitive assessment software Cognitive assessment software Cognitive assessment software Cognitive assessment software Cognitive assessment software Cognitive assessment software Cognitive assessment software Cognitive assessment software Cognitive assessment software Cognitive assessment software Cognitive assessment software Cognitive assessment software Cognitive assessment software Cognitive assessment software

• Primary Device ID: 00864127000332
• NIH Device Record Key: ccddb308-3642-4e52-be32-1d0518d01e58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cognitive Impairment Screener
• Version Model Number: 1
• Company DUNS: 805665101
• Company Name: IMPACT APPLICATIONS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00864127000332 [Primary]

FDA Product Code

• PTY: Computerized Cognitive Assessment Aid, Exempt

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-24
• Device Publish Date: 2020-12-16

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
• 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: 2018-07-06 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