BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NXSTAGE CARTRIDGE EXPRESS

    DI: M535CAR5060 · Model: CAR-506 · NXSTAGE MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NXSTAGE CARTRIDGE EXPRESS
    Primary DI
    M535CAR5060
    Version / Model
    CAR-506
    Company Name
    NXSTAGE MEDICAL, INC.
    Labeler DUNS
    088013219
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-09-01
    Public Version
    3
    Public Version Date
    2018-11-08
    Public Version Status
    Update
    Public Device Record Key
    abc64c4c-13c1-4b7f-906f-02c5dbcca54e

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

    GMDN Terms

    Code Name
    61674 Haemodialysis/haemofiltration system component set

    Identifiers

    Type ID
    Package M535CAR5065
    Primary M535CAR5060

    Customer Contacts

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

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    15 – 30 Degrees Celsius