BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Changer, Tube, Endotracheal

    PMA: P800068 · Supplement: S001 · Decision Jul 23, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Changer, Tube, Endotracheal
    Trade Name
    ENDOTRACHEAL TUBE CHANGER
    PMA Number
    P800068
    Supplement Number
    S001
    Device Class
    FDA Class 2
    Product Code
    LNZ
    Generic Name
    Changer, tube, endotracheal
    Regulation Number
    868.5730
    Medical Specialty
    Anesthesiology
    Advisory Committee
    Anesthesiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 23, 1999
    Date Received
    June 2, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the following changes: 1)Changes in manufacturing: a) new vendor for lumen extrusion; b) new vendor for imprinting the ink (reacted with a hardener) onto the tube changer; and c) eight additional sizes and three additional colors. 2) Change in labeling: a) change in the indications for use statement to reflect the eight new models; and b) revisions in the instructions for use.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LNZ Changer, Tube, Endotracheal