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Kenosha Reporter

Saturday, November 23, 2024

Vonco Products Receives FDA 510(k) Clearance for Novel Closed-Loop Enteral Feeding Solution – EnteraLoc™ Flow

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Vonco Products recently issued the following announcement.

Vonco Products LLC, an industry-leading contract manufacturer of liquid-tight medical fluid bags and devices, biohazard transport, and infection prevention PPEs and device covers, today announced that the patented EnteraLoc™ Flow direct-connect enteral nutritional delivery system was granted 510(k) clearance by the U.S. Food and Drug Administration (FDA).

The EnteraLoc Flow spouted pouch with ENFit® connector was developed with insight from patients, clinicians, and brand owners. It is the first seamless, closed-loop enteral feeding solution that combines a leak-proof seal, direct-connect ENFit® device, tube and nutritious food options in one complete feeding system.

Keith Smith, CEO of Vonco Products, said, “We’re thrilled to offer a solution that helps delivers better enteral care. EnteraLoc is designed to improve the nutrition of enteral patients by providing a convenient method of food delivery that is simple, safe, no mess, and can be consumed on-the-go.”

FOR ENTERAL PATIENTS:

The EnteraLoc Flow spouted pouch dispenses prepared, prepackaged nutrition by way of direct connection to a feeding tube or extension set. Easy to use and without mess, it can deliver nutrition into the gastrointestinal system of a patient in either the hospital or home care setting and can be tailored to meet almost every dietary requirement.

Additional benefits to patients include:

  • Easy to use
  • Better nutrition
  • Reduce messy waste
  • Saves time
  • More mobility
FOR BRAND OWNERS:

EnteraLoc Flow is a contract manufactured medical device sold by brand owners (using their liquid or blenderized formula) direct to hospitals, health systems and home care patients. As a turnkey solution, EnteraLoc reduces the complexity, cost and risk of sourcing, manufacturing, and distributing enteral feeding. It also features a leak-proof seal which reduces shipping/storage waste and spoilage.

Contract manufactured EnteraLoc includes:

  • Complete risk-free turnkey solution
  • Fast custom development and private labelling
  • Preferred nutrition formulations
  • Multiple package sizes
  • High pressure processing
  • Automated filling/retort
  • Leak-proof seal guarantee
“We’ve dramatically reduced the risk to brand owners by offering turnkey contract manufacturing services,” said Kyle Vlasak, vice president of sales at Vonco. “Our enteral feeding system can be fully customized by the brand owner, including preferred formulation, pouch designs, shapes, sizes, hang holes and spout locations.”

To learn more, visit the EnteraLoc website, call 800.323.9077 or email sales@vonco.com.

Vonco is an FDA registered facility with Class II medical device capability and is ISO 13485:2016 Certified.

Original source can be found here.

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