BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    X-Series

    DI: 00851113007451 · Model: XS02-4351 · 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
    00851113007451
    Version / Model
    XS02-4351
    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
    5
    Public Version Date
    2018-10-22
    Public Version Status
    Update
    Public Device Record Key
    fb603bbc-db2c-494c-90b2-bbbb4ea0103c

    Device Description

    Synapse Cream Kit

    Device Characteristics

    Single Use
    Yes
    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
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    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
    11425 Electrode conductive medium

    Identifiers

    Type ID
    Primary 00851113007451

    Premarket Submissions

    Submission Number Supplement Number
    K131383 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    7 – 20 Degrees Celsius
    Type
    Handling Environment Temperature
    Temperature Range
    7 – 20 Degrees Celsius