FDA Product Code FRN: Pump, Infusion

Accurate drug delivery is critical to patient safety in every care setting. FDA product code FRN covers infusion pumps used for the controlled delivery of fluids and medications.

These devices deliver precise volumes of drugs, nutrients, or fluids at programmed rates via intravenous, subcutaneous, or enteral routes. They range from large-volume pumps for IV fluids to syringe drivers for concentrated analgesics and chemotherapy.

FRN devices are Class II medical devices, regulated under 21 CFR 880.5725 and reviewed by the FDA General Hospital panel.

Leading manufacturers include Baxter Healthcare Corporation, Icu Medical, Inc. and Zevex, Inc..