BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sleep Profiler

    DI: 00851113007215 · Model: SP40-4101 · ADVANCED BRAIN MONITORING, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Sleep Profiler
    Primary DI
    00851113007215
    Version / Model
    SP40-4101
    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
    2023-06-20
    Public Version Status
    Update
    Public Device Record Key
    99c8da6c-0ea2-4595-a279-37b2574bb410

    Device Description

    Sleep Profiler Headband Kit

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OLV Standard Polysomnograph With Electroencephalograph
    OMC Reduced- Montage Standard Electroencephalograph

    GMDN Terms

    Code Name
    35709 Electrode/transducer strap, reusable

    Identifiers

    Type ID
    Package 20851113007219
    Primary 00851113007215
    Package 10851113007212

    Premarket Submissions

    Submission Number Supplement Number
    K120447 000
    K130013 000
    K152040 000