FDA Product Code LHI: Set, I.v. Fluid Transfer

Under FDA product code LHI, IV fluid transfer sets are cleared for the transfer of sterile fluids between containers.

These sterile, closed-system tubing sets enable aseptic transfer of intravenous solutions from bulk containers to IV bags or bottles without exposing the fluid to the environment. They are used in pharmacy compounding and clinical preparation of IV admixtures.

LHI devices are Class II medical devices, regulated under 21 CFR 880.5440 and reviewed by the FDA General Hospital panel.

Leading manufacturers include Hangzhou Qiantang Longyue Biotechnology Co., Ltd., Sfm Medical Devices GmbH and Yukon Medical, LLC.