BEUDAMED
    Product Code: FIJ FDA class 2 21 CFR 876.5820

    System, Dialysate Delivery, Recirculating, Single Pass

    Gastroenterology, Urology

    The Recirculating Single Pass Dialysate Delivery System is a hemodialysis subsystem that delivers dialysate in a single-pass manner while recirculating components of the circuit for efficiency. It is classified as FDA Class 2, requiring 510(k) premarket clearance, and is considered life-sustaining or life-supporting. The product code is FIJ, regulated under 21 CFR 876.5820, within the Gastroenterology, Urology specialty.

    View on FDA
    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    FIJ
    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 1 510(k) clearance via K numbers.

    K Number Device Name
    K772163 DIALYSIS MACHINES DM-346 & 346-1