BEUDAMED
    Product Code: OYI FDA class 1 21 CFR 868.6810

    Non-Bronchoscopic Bronchoalveolar Lavage Catheter

    Anesthesiology

    The Non-Bronchoscopic Bronchoalveolar Lavage Catheter is an anesthesiology device used to perform bronchoalveolar lavage (BAL) in adult patients undergoing mechanical ventilation without the need for bronchoscopy. It is classified as Class 1 (FDA Class 1), subject to general controls with no 510(k) exemption, under regulation 868.6810. The product code is OYI under the Anesthesiology medical specialty.

    View on FDA
    510(k)s
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    OYI
    Device Class
    FDA class 1
    Regulation Number
    868.6810
    Medical Specialty
    Anesthesiology
    Review Panel
    AN
    Submission Type
    4

    Device Characteristics

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

    Definition

    To perform non-bronchoscopic bronchoalveolar lavage (bal) in adult patients undergoing mechanical ventilation.

    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
    K112562 BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER

    FEI Numbers

    This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.