Contact US

NeoMed Receives FDA 510(k) Clearance for NeoConnect™ Enteral Syringes with ENFit™ Connector.

Woodstock, GA – May 29, 2015 NeoMed, Inc., a market leader and inno­vator of neonatal nutrition/enteral safety devices, announced that it received FDA 510(K) clear­ance from the United States Food and Drug Administration (FDA) for its NeoConnect Enteral Syringes with ENFit connector (K143344) on April 8, 2015.  NeoMed is currently one of only two enteral syringe manu­fac­turers that have received FDA 510(K) clear­ance for enteral syringes with ENFit connec­tors.

The NeoConnect syringes are an impor­tant part of the NeoMed solu­tions for the ISO 80369-3 (ENFit) Small Bore Connector Standard, being imple­mented to help reduce the risk of tubing miscon­nec­tions and improve patient safety. NeoMed designed the first compre­hen­sive enteral safety system to comply with the recom­men­da­tions of the Joint Commission, FDA, ASPEN, and AAMI to help prevent tubing miscon­nec­tions and is proud to support the ENFit initia­tive.

Aaron Ingram, President of NeoMed, Inc. says “Our commit­ment to our customers is our continual partic­i­pa­tion with GEDSA, the trade asso­ci­a­tion created to help intro­duce the new stan­dards. We will continue our support of the new ISO 80369-3 stan­dard through imple­men­ta­tion, prac­tice, and beyond.”

“NeoConnect repre­sents a port­folio of intel­lec­tual prop­erty and embodies the unwa­vering commit­ment of NeoMed to pursue inno­v­a­tive solu­tions that help the most vulner­able patient – the neonate,” commented NeoMed CEO Tony Lair. “We are excited to be able to provide our customers with a full line of NICU and phar­macy prod­ucts to help them navi­gate the imple­men­ta­tion of ENFit enteral access devices.”

NeoConnect prod­ucts will be avail­able to customers in align­ment with the GEDSA time­line for intro­duc­tion of ENFit (