BEUDAMED
    Product Code: MSZ FDA class 2 21 CFR 876.5665

    Strip, Test, Reagent, Residuals For Dialysate

    Gastroenterology, Urology

    A Reagent Test Strip for Dialysate Residuals is a chemical indicator device used to verify that residual substances in dialysate are within safe limits, supporting quality control in dialysis procedures and protecting patients from exposure to harmful concentrations of dialysate components. It is FDA Class 2, requiring 510(k) clearance, with product code MSZ under 21 CFR 876.5665 in the Gastroenterology and Urology specialty, and is designated as life-sustaining. The device is not an implant.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    MSZ
    Device Class
    FDA class 2
    Regulation Number
    876.5665
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    1

    Device Characteristics

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