FDA Product Code BTR: Tube, Tracheal (w/wo Connector)

FDA product code BTR covers tracheal tubes used to maintain an open airway during anesthesia, mechanical ventilation, and emergency airway management.

These tubes are inserted through the mouth or nose into the trachea to provide a secure, controlled airway that prevents aspiration and enables mechanical ventilation. They are available with or without inflatable cuffs, in a range of sizes for adults and children.

BTR devices are Class II medical devices, regulated under 21 CFR 868.5730 and reviewed by the FDA Anesthesiology panel.

Leading manufacturers include Sheridan Catheter Corp., Mallinckrodt Critical Care and Bivona Medical Technologies.