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 (www.stayconnected.org).