21 CFR 880.5420 — Infusor, Pressure, For I.V. Bags
General Hospital (HO) · Part 880 Subpart F—General Hospital and Personal Use Therapeutic Devices · § 880.5420
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KZD | Infusor, Pressure, For I.V. Bags | 1 | 35 |
