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 Jiangsu Caina Medical Co.,Ltd and Cardinalhealth.
List of Enteral Syringes With Enteral Specific Connectors devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Enteral Syringes With Enteral Specific Connectors devices (product code PNR). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Gastroenterology & Urology FDA review panel. Browse all Gastroenterology & Urology devices →