BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    X-Series

    DI: 00851113007420 · Model: 03-5105 · ADVANCED BRAIN MONITORING, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    X-Series
    Primary DI
    00851113007420
    Version / Model
    03-5105
    Company Name
    ADVANCED BRAIN MONITORING, INC.
    Labeler DUNS
    969842715
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-12-27
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    5c17661b-5c9c-4afa-b491-72063ab2d53f

    Device Description

    External Battery USB Custom Cable

    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
    Yes
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OMC Reduced- Montage Standard Electroencephalograph
    GWQ Full-Montage Standard Electroencephalograph

    GMDN Terms

    Code Name
    47487 Electrical-only medical device connection cable, reusable

    Identifiers

    Type ID
    Primary 00851113007420

    Premarket Submissions

    Submission Number Supplement Number
    K131383 000