BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HiPAL Pro

    DI: G527GTDHIPALPRO01V1010 · Model: 1.0.1 · GT DIAGNOSTICS (UK) LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HiPAL Pro
    Primary DI
    G527GTDHIPALPRO01V1010
    Version / Model
    1.0.1
    Catalog Number
    GTD-HiPALPro-01
    Company Name
    GT DIAGNOSTICS (UK) LIMITED
    Labeler DUNS
    226236192
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-07-28
    Public Version
    1
    Public Version Date
    2023-08-07
    Public Version Status
    New
    Public Device Record Key
    e12b14b1-92ec-4fdc-9eab-7868487899a2

    Device Description

    HiPAL Pro is a mobile application that presents a short, language independent, cognitive assessment. HiPAL Pro is self- administered but must be prescribed and must have results evaluated by a licensed medical professional. Moreover, HiPAL Pro must be initiated and supervised by professionals experienced in the use of cognitive assessment tools. The output score is aimed at screening for as well as aiding diagnosis and monitoring of Alzheimer’s disease (AD) and Cognitive Impairment. Scores are reviewed and interpreted by a licensed medical professional through an accompanying web portal.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    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
    PTY Computerized Cognitive Assessment Aid, Exempt

    GMDN Terms

    Code Name
    63185 Cognitive assessment software

    Identifiers

    Type ID
    Primary G527GTDHIPALPRO01V1010