DEVICE: HMS System™ (EBES8200070)

A non-sterile substance made of oil (e.g., paraffin) designed to be applied by healthcare staff or a patient to the outer surface of a tracheostomy tube inner cannula to facilitate its easy sliding into the outer cannula (e.g., after cleaning). The lubrication is intended to reduce frictional forces so that less physical force is required for inner cannula insertion and to help prolong the life of the tube's cannulae. It is typically available in a squeeze or dropper bottle. After application, this device cannot be reused.

An implantable artificial substitute for the natural trachea used in airway reconstructive surgery. It is typically a semi-rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal trachea prosthesis may be uncovered or covered with a polymeric material.