FDA Product Code PNR: Enteral Syringes With Enteral Specific Connectors

Safe enteral nutrition delivery requires connectors that cannot be accidentally connected to intravenous lines. FDA product code PNR covers enteral syringes with enteral-specific connectors.

These syringes use ENFit or other enteral-specific connector designs that are physically incompatible with IV Luer connectors, preventing the catastrophic error of accidentally injecting enteral formula into the bloodstream.

PNR devices are Class II medical devices, regulated under 21 CFR 876.5980 and reviewed by the FDA Gastroenterology & Urology panel.

Leading manufacturers include Covidien, Jiangsu Caina Medical Co.,Ltd and CMT Health PTE., Ltd..