BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ANAM Test System: Military, Military Expanded, Core, Core Expanded, and Sports

    DI: 00860334002138 · Model: 4.5.0.8 · VISTA PARTNERS, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ANAM Test System: Military, Military Expanded, Core, Core Expanded, and Sports
    Primary DI
    00860334002138
    Version / Model
    4.5.0.8
    Company Name
    VISTA PARTNERS, LLC
    Labeler DUNS
    191819023
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-11-24
    Public Version
    1
    Public Version Date
    2025-12-02
    Public Version Status
    New
    Public Device Record Key
    f167c6f8-46e5-4715-918d-f3c0519cb267

    Device Description

    The ANAM® Test System: Military, Military Expanded, Core, Core Expanded, and Sports Batteries are intended for use as computer-based neurocognitive test batteries to aid in the assessment and management of mild traumatic brain injury. The ANAM Test System is a software only device that provides clinicians with objective measurements of cognitive performance to aid in the assessment of an individual’s level of cognitive performance. The ANAM Test System provides precise, objective, and repeatable automated measures of neurocognitive functions including response speed, attention/concentration, immediate and delayed memory, spatial processing, and decision processing speed and efficiency. It can be used to screen for general cognitive impairment within initial triage assessment/decision making or to obtain a more refined and detailed information regarding a person’s neurocognitive status. The battery is also specially designed for longitudinal assessment of cognitive functioning and can be used 1) to monitor progression of disease status; 2) to track cognitive change or recovery; and 3) to monitor the cognitive effects of medical interventions. The ANAM Test System provides both absolute and relative information about the test taker’s performance. Test performance following an injury, event, or intervention can be assessed by comparing a person’s test result to a previous testing point or to a pre-existing “baseline” if those data are available. If pre-existing testing data are unavailable, the ANAM Test System will provide a comparison of performance in relationship to a selected normative/reference group. The ANAM Performance Report software program will automatically provide comparisons to selectable reference groups as well as to the test taker’s previous testing data, if available.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    POM Computerized Cognitive Assessment Aid For Concussion

    GMDN Terms

    Code Name
    58290 Psychological assessment software

    Identifiers

    Type ID
    Primary 00860334002138

    Customer Contacts

    Phone
    888-733-8804
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K201376 000