BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NSO PLUS, NXSTAGE SYSTEM ONE PLUS

    DI: M535NX1000100 · Model: NX1000-10 · NXSTAGE MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NSO PLUS, NXSTAGE SYSTEM ONE PLUS
    Primary DI
    M535NX1000100
    Version / Model
    NX1000-10
    Company Name
    NXSTAGE MEDICAL, INC.
    Labeler DUNS
    088013219
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-06-02
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    37924ead-1d3d-4e7a-b35f-a580695475ab

    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
    KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

    GMDN Terms

    Code Name
    58131 Haemodialysis system, institutional/home-use

    Identifiers

    Type ID
    Primary M535NX1000100

    Customer Contacts

    Phone
    1-866-697-8243
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -25 – 70 Degrees Celsius