BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DreamStation Go

    DI: 00606959054783 · Model: DSG400H11 · Respironics, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DreamStation Go
    Primary DI
    00606959054783
    Version / Model
    DSG400H11
    Catalog Number
    DSG400H11
    Company Name
    Respironics, Inc.
    Labeler DUNS
    080728314
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-02-20
    Public Version
    2
    Public Version Date
    2023-02-06
    Public Version Status
    Update
    Public Device Record Key
    ac211746-8ecc-4048-8024-b45ee5be22bb

    Device Description

    DreamStation Go CPAP with Humidifier, Domestic

    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
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    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
    BZD VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

    GMDN Terms

    Code Name
    60711 Home CPAP unit

    Identifiers

    Type ID
    Primary 00606959054783

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -4 – 140 Degrees Fahrenheit
    Type
    Storage Environment Humidity
    Temperature Range
    15 – 95 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    -20 – 60 Degrees Celsius