BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SleepView Starter Kit

    DI: B1437000011112 · Model: International · Cleveland Medical Devices Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SleepView Starter Kit
    Primary DI
    B1437000011112
    Version / Model
    International
    Catalog Number
    700-0011-11
    Company Name
    Cleveland Medical Devices Inc.
    Labeler DUNS
    557510625
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    4
    Public Version Date
    2022-11-28
    Public Version Status
    Update
    Public Device Record Key
    7347c9d7-7156-44a4-a611-bebaa230fcd7

    Device Description

    SleepView International 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 B1437000011112

    Premarket Submissions

    Submission Number Supplement Number
    K042039 000