---
kind: "section"
citation: "21 C.F.R. § 880.5420"
title: "21"
number: "880.5420"
heading: "Pressure infusor for an I.V. bag."
url: "https://uscodex.org/cfr/21/880.5420"
---

# §880.5420. Pressure infusor for an I.V. bag.

- (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](/cfr/21/part807-subpartE.md) of this chapter subject to [§ 880.9](/cfr/21/880.9.md).

## Notes

### Amendments

[45 FR 69682, Oct. 21, 1980, as amended at 65 FR 2318, Jan. 14, 2000]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 45 FR 69682, Oct. 21, 1980, unless otherwise noted.

### Amendments

[45 FR 69682, Oct. 21, 1980, as amended at 65 FR 2318, Jan. 14, 2000]