BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    GoodKnight

    DI: 03700659400301 · Model: GoodKnight H2O · SEFAM
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    GoodKnight
    Primary DI
    03700659400301
    Version / Model
    GoodKnight H2O
    Catalog Number
    M-114600
    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
    a531cfff-8348-40d0-9604-ac5dfdd5d163

    Device Description

    GoodKnight H2O is a heated humidifier designed to be used with PAP devices of the GoodKnight series.

    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
    BTT Humidifier, Respiratory Gas, (Direct Patient Interface)

    GMDN Terms

    Code Name
    12050 Heated respiratory humidifier

    Identifiers

    Type ID
    Primary 03700659400301