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FDA 510(k) Clearance for NeoMed's Low Dose Tip ENFit Syringe Announced by Healthcare Purchasing News

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6/22/2016

NeoMed receives FDA 510(k) clear­ance for its Low Dose Tip ENFit Syringe

NeoMed, 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.

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.

The NeoConnect family of ENFit prod­ucts addresses recom­men­da­tions from industry leaders such as GEDSA, ISMP, the Joint Commission, ASHP, and ASPEN.

Link to HPN story