BEUDAMED
    Product Code: EXH FDA class 1 21 CFR 876.5900

    Bag, Urinary, Ileostomy

    Gastroenterology, Urology

    The ileostomy urinary bag is a collection device used by patients with an ileal conduit or other urinary diversion via ileostomy to collect urine output from a surgically created stoma. It is classified as FDA Class 1, indicating minimal risk, subject only to general controls and no premarket notification requirement. The product code is EXH, regulated under 21 CFR 876.5900 in the Gastroenterology, Urology specialty. No special regulatory flags apply.

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    510(k)s
    0
    FEI Numbers
    23
    Registration Numbers
    23
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    EXH
    Device Class
    FDA class 1
    Regulation Number
    876.5900
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    4

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 23 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 23 registration numbers. Click on an entry to view related FDA registrations.