BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    GoodKnight

    DI: 03700659400264 · Model: GoodKnight 420S · SEFAM
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    GoodKnight
    Primary DI
    03700659400264
    Version / Model
    GoodKnight 420S
    Catalog Number
    M-113903
    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
    1a29112d-b539-44a4-a74f-5d13a8c3b4f0

    Device Description

    GoodKnight 420S is a sleep apnea therapy device (PAP device) with advanced recording features.

    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 03700659400264