BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    SleepScout Starter Kit

    DI: B143700000712 · Model: Standard · Cleveland Medical Devices Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SleepScout Starter Kit
    Primary DI
    B143700000712
    Version / Model
    Standard
    Catalog Number
    700-0007-1
    Company Name
    Cleveland Medical Devices Inc.
    Labeler DUNS
    557510625
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    5
    Public Version Date
    2023-08-09
    Public Version Status
    Update
    Public Device Record Key
    813c014a-c77b-4c24-be65-298ad16d7afb
    Distribution End Date
    2018-12-31

    Device Description

    SleepScout Starter Kit

    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
    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
    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

    GMDN Terms

    Code Name
    11467 Electroencephalograph

    Identifiers

    Type ID
    Primary B143700000712

    Premarket Submissions

    Submission Number Supplement Number
    K042039 000