§ 880.5420. Pressure infusor for an I.V. bag.
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/us/cfr/t21/s§ 880.5420·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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. [45 FR 69682, Oct. 21, 1980, as amended at 65 FR 2318, Jan. 14, 2000]