§ 868.5800. Tracheostomy tube and tube cuff.
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/us/cfr/t21/s§ 868.5800·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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. [51 FR 40389, Nov. 6, 1986]