Vonco Products LLC, a leading manufacturer in risk-free plastics and packaging, is thrilled to announce that the U.S. Food and Drug Administration (FDA) has granted clearance for EnteraLoc Flow as an over-the-counter (OTC) direct-connect feeding solution for enteral patients.

Each year, over 1 million patients in the United States rely on feeding tubes to sustain their lives or aid in their healing processes. By introducing EnteraLoc Flow as an OTC feeding solution, individuals on enteral feeding regimens and their caregivers will now have the option to purchase it without the need for a prescription. This marks a significant advancement in the quest to enhance the health, mobility, and quality of life for enteral patients, offering them superior choices for nutritional formulations and methods of delivery. EnteraLoc Flow initially received FDA clearance in 2021 under the 510(k) category (Rx Only).

Keith Smith, CEO of Vonco Products, expressed his satisfaction with the FDA's decision, stating, "We're extremely pleased with the FDA's decision. EnteraLoc Flow has been designed to enhance the nutrition of enteral patients by providing a convenient and safe food delivery method that minimizes mess and allows for on-the-go consumption. Designating EnteraLoc Flow as an OTC solution will aid physicians and caregivers in delivering improved enteral care."

To secure the OTC classification, Vonco presented Human Factors study data that overwhelmingly demonstrated the safety and effectiveness of the EnteraLoc Flow feeding system, along with clear and comprehensible usage instructions for the average person.

"Proper nutrition can be life-saving for enteral patients," remarked David Marks, President and CEO of Medtrition, a global supplier of medical foods. "Being able to administer enteral nutrition quickly and safely with a simple squeeze of a pouch equipped with the EnteraLoc Flow direct-connect ENFit® device revolutionizes enteral tube feeding. As a valued partner of Vonco, we eagerly anticipate expanding our enteral offerings to include the EnteraLoc Flow OTC feeding system. When combined with nutritious formulations, I believe there is no better feeding solution for the home enteral community."

EnteraLoc Flow is a contract-manufactured solution sold by brand owners directly to hospitals, health systems, and home care patients. The company anticipates that the OTC version will be available through online retail by late 2023. In the interim, the product will remain readily accessible through existing distribution channels.

For more information, please visit the EnteraLoc website, contact them at 800.323.9077, or send an email to sales@vonco.com.

Vonco is an FDA-registered facility with Class II medical device capabilities and holds ISO 13485:2016 certification.

Source:businesswire.com

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