FDA Clears Closed-Loop Enteral Feeding Solution

Vonco Products LLC, a contract manufacturer of liquid-tight medical fluid bags and devices, biohazard transport, and infection prevention PPEs and device covers, said its 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.”
 
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: ease of use, better nutrition, reduction of messy waste, saves time, and more mobility.
 
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: a complete risk-free turnkey solution, fast custom development and private labelling, preferred nutrition formulations, multiple package sizes, high-pressure processing, automated filling/retort, and a 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.”
 
Vonco is an FDA-registered facility with Class II medical device capability and is ISO 13485:2016 certified.
 
Vonco is a contract manufacturer of liquid-tight medical device and consumer stand up pouches. The company provides fast custom design for the ‘craziest’ of bags with unique shapes, fitment insertions and assembly of unsupported or laminated films. Vonco is a member of GEDSA.