FDA Product Code FMI: Needle, Hypodermic, Single Lumen

FDA product code FMI covers single-lumen hypodermic needles.

These devices consist of a hollow metallic cannula with a sharpened beveled tip designed to pierce skin and tissue for the injection of medications, aspiration of fluids, or delivery of vaccines. They are among the most widely used medical devices globally, available in a wide range of gauges and lengths.

FMI devices are Class II medical devices, regulated under 21 CFR 880.5570 and reviewed by the FDA General Hospital panel.

Leading manufacturers include Bd Becton Dickinson Vacutainer Systems Preanalytic, Promisemed Hangzhou Meditech Co., Ltd. and Baxter Healthcare Corp.