21 C.F.R. § 868.5800

Current through April 30, 2024
Section 868.5800 - Tracheostomy tube and tube cuff
(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.

21 C.F.R. §868.5800

51 FR 40389, Nov. 6, 1986