BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    GoodKnight

    DI: 03700659400271 · Model: GoodKnight 420E · SEFAM
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    GoodKnight
    Primary DI
    03700659400271
    Version / Model
    GoodKnight 420E
    Catalog Number
    M-113902
    Company Name
    SEFAM
    Labeler DUNS
    262411625
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-10
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    f92b6528-d914-431d-bb13-65e54129cead

    Device Description

    GoodKnight 420E is a sleep apnea therapy device with auto-adjustable algorithm (A-PAP device)

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    BZD Ventilator, Non-Continuous (Respirator)

    GMDN Terms

    Code Name
    60711 Home CPAP unit

    Identifiers

    Type ID
    Primary 03700659400271