BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    X-Series, X8

    DI: 00851113007260 · Model: 31-1003 · ADVANCED BRAIN MONITORING, INC.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    X-Series, X8
    Primary DI
    00851113007260
    Version / Model
    31-1003
    Company Name
    ADVANCED BRAIN MONITORING, INC.
    Labeler DUNS
    969842715
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    5
    Public Version Date
    2021-11-10
    Public Version Status
    Update
    Public Device Record Key
    83fed772-bf62-446e-91ed-5671185318e6

    Device Description

    Bluetooth Dongle

    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
    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
    GWQ Full-Montage Standard Electroencephalograph
    OLV Standard Polysomnograph With Electroencephalograph
    OMC Reduced- Montage Standard Electroencephalograph

    GMDN Terms

    Code Name
    32547 Medical networking interface unit

    Identifiers

    Type ID
    Primary 00851113007260

    Premarket Submissions

    Submission Number Supplement Number
    K131383 000
    K152040 000