21 CFR 868.5800
§ 868.5800 Tracheostomy tube and tube cuff.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 868.5800, § 868.5800 Tracheostomy tube and tube cuff, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89836
- Permanent ID
ys:prov:89836@1- SHA-256
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.