Tracheostomy tube and tube cuff.

21 C.F.R. § 868.5800
in effectEffective: 2024-07-01
Sign in to generate a plain English summaryAsk Belisarius Agent
(a) Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic. (b) Classification. Class II.

Starting a business? Corpus forms LLCs in all 50 states and DC.