BEUDAMED
    Product Code: NIH FDA class 2 21 CFR 876.5665

    Disinfectant, Subsystem, Water Purification

    Gastroenterology, Urology

    The Water Purification Subsystem Disinfectant is a chemical disinfectant intended for reprocessing water purification systems used in hemodialysis. It is classified as FDA Class 2 (Special Controls), requiring a de novo or 510(k) pathway, under product code NIH and regulation 21 CFR 876.5665 in the Gastroenterology and Urology specialty (reviewed by the General Hospital panel). The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    NIH
    Device Class
    FDA class 2
    Regulation Number
    876.5665
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    HO
    Submission Type
    4

    Device Characteristics

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

    Definition

    Disinfectant intended for reprocessing water purification systems for hemodialysis.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K133724 MINNCARE HD

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.