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NeoMed Receives FDA 510(k) Clearance for its Low Dose Tip ENFit® Syringe

NeoMed, a leading devel­oper and manu­fac­turer of enteral collec­tion and delivery prod­ucts for the special­ized needs of low birth weight, neonatal and pedi­atric patients, has received FDA 510(k) clear­ance for our NeoConnect™ Low Dose Tip (LDT) Oral/Enteral ENFit* Syringes. NeoMed’s LDT ENFit Syringes, when used as intended, achieve accu­rate small volume doses while mini­mizing the risk of miscon­nec­tions.  The LDT tech­nology will be avail­able on NeoMed’s 0.5 mL, 1 mL, 3 mL and 6 mL ENFit syringes. The addi­tion of the LDT tech­nology completes NeoMed’s full port­folio of ENFit syringes in advance of the July 2016 California legisla­tive mandate for all hospi­tals to provide a dedi­cated safety enteral system.

This FDA 510(k) clear­ance also included direct oral admin­is­tra­tion indi­ca­tions for use of all NeoConnect syringes with ENFit connec­tors. The ability to utilize a NeoConnect syringe (low dose or stan­dard) for both oral and enteral delivery of fluids means that a facility will not have to main­tain a sepa­rate inven­tory of legacy oral syringes once they tran­si­tion to ENFit.
Aaron IngramAaron Ingram, President of NeoMed stated, “NeoMed has been a leader in the ENFit initia­tive repre­senting the unique needs of the neonatal, pedi­atric and phar­macy customer. We pride ourselves as a company that strives to achieve the highest level of patient care and safety through product design, inno­va­tion, and quality. The LDT solu­tion is a perfect example of this.”

 

Melinda Smith, VP of Quality and Regulatory Affairs stated, “A tremen­dous effort by a very talented cross-functional team span­ning many enteral device manu­fac­turers across the globe allowed us to reach this enor­mous mile­stone in such a short period of time and NeoMed thanks everyone involved.”

 

Ben Davis, VP of Engineering and Product Development added, “NeoMed’s Low Dose Tip design and the unique design features of our ENFit product family repre­sent a para­digm shift in the direc­tion of patient safety and clin­ical effi­cacy. This 510(k) marks the begin­ning of a new chapter in patient care and we are honored to lead the way.”

 

NeoMed devel­oped the low dose tip design, which is now being adopted by industry, and has offered all syringe manu­fac­turers royalty free access to the design. This 510(k) clear­ance is a crit­ical mile­stone for the clin­ical commu­nity to support the launch of ENFit prod­ucts. It also demon­strates NeoMed’s commit­ment to improve patient outcomes through product designs that meet safety, clin­ical, and regu­la­tory guide­lines. The NeoConnect family of ENFit prod­ucts addresses recom­men­da­tions from industry leaders such as GEDSA, ISMP, the Joint Commission, ASHP, and ASPEN.