21 CFR 868.5375
§ 868.5375 Heat and moisture condenser (artificial nose).
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 868.5375, § 868.5375 Heat and moisture condenser (artificial nose), United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89799
- Permanent ID
ys:prov:89799@1- SHA-256
cfdf92eb965ea84237a104fc98997c09f837b5453011a48a3fa758cc20e551f6
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Full text
(a) Identification. A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidify gases breathed in by a patient.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.