BEUDAMED
    Product Code: FID FDA class 2 21 CFR 876.5820

    Tubing, Dialysate

    Gastroenterology, Urology

    The Dialysate Tubing is a set of tubes used to convey dialysate solution between the dialysis machine and the dialyzer during hemodialysis, forming part of the extracorporeal circuit. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance, and is considered life-sustaining or life-supporting. The product code is FID, regulated under 21 CFR 876.5820, within the Gastroenterology, Urology specialty.

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    510(k)s
    3
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    2
    Years Active
    26

    Basic Information

    Product Code
    FID
    Device Class
    FDA class 2
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    1

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 3 510(k) clearances via K numbers.

    K Number Device Name
    K022068 TUBING, DIALYSATE (AND CONNECTOR)
    K010712 DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES
    K770299 TYGON M-60/TYGON M-70

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.