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NeoMed Receives FDA 510(k) Clearance for Additional Sizes of Sterile Oral Enteral Syringes

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.