BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Core Cognitive Evaluation

    DI: B626200050 · Model: 20005 · Linus Health, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Core Cognitive Evaluation
    Primary DI
    B626200050
    Version / Model
    20005
    Catalog Number
    20005
    Company Name
    Linus Health, Inc.
    Labeler DUNS
    117137874
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-06-05
    Public Version
    1
    Public Version Date
    2024-06-13
    Public Version Status
    New
    Public Device Record Key
    3817a706-98c7-4268-b762-95d24593e342

    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    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 B626200050