BEUDAMED
    Product Code: NII FDA class 2 21 CFR 876.5860

    Disinfectant, Dialysate Delivery System

    Gastroenterology, Urology

    The Dialysate Delivery System Disinfectant is a chemical disinfectant intended for reprocessing dialysate delivery systems used in hemodialysis. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NII and regulation 21 CFR 876.5860 in the Gastroenterology and Urology specialty. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    2
    FEI Numbers
    12
    Registration Numbers
    12
    Unique Applicants
    2
    Years Active
    2

    Basic Information

    Product Code
    NII
    Device Class
    FDA class 2
    Regulation Number
    876.5860
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    HO
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Disinfectant intended for reprocessing dialysate delivery systems.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 2 510(k) clearances via K numbers.

    K Number Device Name
    K043207 OZONE GENERATOR
    K023064 HEMOCLEAN

    FEI Numbers

    This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.