BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BrainScope One

    DI: 00852745007123 · Model: 99-1403-002 · Brainscope Company, Inc.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BrainScope One
    Primary DI
    00852745007123
    Version / Model
    99-1403-002
    Company Name
    Brainscope Company, Inc.
    Labeler DUNS
    805670416
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-09-24
    Public Version
    4
    Public Version Date
    2023-09-27
    Public Version Status
    Update
    Public Device Record Key
    4b820149-bdfe-4636-b709-250e80e54b64

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    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
    OLU Normalizing Quantitative Electroencephalograph Software
    PKQ Computerized Cognitive Assessment Aid
    PIW Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid

    GMDN Terms

    Code Name
    11467 Electroencephalograph

    Identifiers

    Type ID
    Primary 00852745007123

    Customer Contacts

    Phone
    240-725-7680
    Email
    [email protected]