21 CFR 868.5800 — Tube, Tracheostomy (W/Wo Connector)

Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5800

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.

Classification Rationale

Class II.

Product Codes