BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SC+ Hemodialysis System

    DI: 05060497260085 · Model: SC-13940 · QUANTA DIALYSIS TECHNOLOGIES LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SC+ Hemodialysis System
    Primary DI
    05060497260085
    Version / Model
    SC-13940
    Company Name
    QUANTA DIALYSIS TECHNOLOGIES LIMITED
    Labeler DUNS
    211298693
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-06-21
    Public Version
    4
    Public Version Date
    2023-07-04
    Public Version Status
    Update
    Public Device Record Key
    efcdbed2-8617-4737-ba71-b384fbe36a06

    Device Description

    Hemodialysis Delivery Device

    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 05060497260085