MCHENRY, Ill., March 9, 2017 /PRNewswire/ -- Medela LLC has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market ENFit Low Dose Tip enteral syringes. When used as intended, the ENFit Low Dose Tip can help to deliver accurate doses while reducing the risk of misconnections. This clearance completes Medela's line of NICU-specific enteral feeding system products, which also includes syringes, syringe pumps, warmers, feeding tubes, and extension sets.
"The ENFit products, including the ENFit Low Dose Syringe, were a natural addition to our neonatal enteral feeding system," said Melissa Gonzales, managing director of Medela LLC for the US market. "As more neonatal intensive care units look to adopt ENFit enteral feeding connectors and ENFit low dose syringes, they will also need dedicated training from their supplier. We're thrilled to provide the product and the support to our customers."
The ENFit design originated with the Global Enteral Device Supplier Association (GEDSA) to address the issue of misconnections in both intensive care hospital and homecare environments. Specific to enteral feeding, the ENFit Low Dose Tip Syringe was created to improve oral medication accuracy, which is especially necessary for small volume delivery in neonatal intensive care units (NICU). This design helps to improve small-volume enteral drug delivery accuracy by preventing unwanted liquid transfer while connecting and disconnecting from the feeding tube.
Founded in 1961, Medela is led by Michael Larsson and concentrates on two business units: "Human Milk," providing research-based breast milk feeding solutions, and "Healthcare," engineering and manufacturing medical vacuum technology solutions. Medela is headquartered in Switzerland and has 18 subsidiaries, distributing its products to more than 100 countries throughout the world. For more information, visit www.medela.com.
Medela is registered in the U.S. Patent and Trademark Office.
ENFit is a federally registered trademark of GEDSA and is used with permission.