21 CFR 880.5420
§ 880.5420 Pressure infusor for an I.V. bag.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 880.5420, § 880.5420 Pressure infusor for an I.V. bag, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90536
- Permanent ID
ys:prov:90536@1- SHA-256
b5fc4a7ee8b6398e513b34c5494d01c91d24fe008dbc93a7bb88b9f6fe4c14ac
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Full text
(a) Identification. A pressure infusor for an I.V. bag is a device consisting of an inflatable cuff which is placed around an I.V. bag. When the device is inflated, it increases the pressure on the I.V. bag to assist the infusion of the fluid.
(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 § 880.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.