21 CFR 868.5320
§ 868.5320 Reservoir bag.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 868.5320, § 868.5320 Reservoir bag, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89794
- Permanent ID
ys:prov:89794@1- SHA-256
1a092c76de4f2e4648d7db21ee887bc6e22075776eeb80b86a84729e4159ba65
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(a) Identification. A reservoir bag is a device, usually made of conductive rubber, intended for use in a breathing circuit as a reservoir for breathing gas and to assist, control, or monitor a patient's ventilation.
(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.