Woodstock, GA – October, 2012 – NeoMed, Inc. announced today that it has received 510(k) clearance by the FDA to extend the NeoMed Sterile Oral Enteral Syringe family to include sizes ranging from 0.5 mL to 100 mL.
This clearance allows NeoMed to produce the FIRST Sterile 100 mL Oral Enteral Syringe on the market. While delivering gravity feeds, the Sterile 100 mL Oral Enteral Syringe has a unique vent zone and plunger fenestration for quick placement on a pole. The Sterile 100 mL Oral Enteral Syringe is currently validated in several leading syringe infusion pumps and is ideal for pump feeds requiring volumes over 60 mL.
NeoMed President Tony Lair commented, "NeoMed is committed to developing and manufacturing the highest quality devices for proper enteral delivery, and our sterile devices from syringes to feeding tubes help ensure that valuable human breast milk has an aseptic pathway to the belly of premature babies." Proper handling and management of human breast milk in patient care settings is an important factor in reducing dangerous gut disease and other hospital born infections. The Sterile 100 mL Oral Enteral Syringe, like all enteral delivery devices in NeoMed's Enteral Safety System, is designed to be incompatible with Luer and IV devices to reduce the risk of misconnection errors.