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GEDSA Announces Testing Results, Acceptance, and Timeline Release of NeoMed’s Low Dose ENFit Syringe

On April 13, 2016, GEDSA made avail­able a summary of the perfor­mance testing for the low dose syringe tip design. The GEDSA Update explains that “the low dose tip ENFit syringe design was found to perform substan­tially equiv­a­lent to stan­dard orien­ta­tion (male) syringes that are commonly used today, and the design was found to outper­form reverse system (female) syringes that are in use today.” Usability testing results demon­strated “Overall, users found the low design feature accept­able for filling and admin­is­tering enteral doses.”

Officially, GEDSA reports that “The low dose syringe is compliant with the ISO 80369-3 stan­dard and will be intro­duced in the market after required regu­la­tory approvals/clearances. The low dose syringe design is avail­able for all manu­fac­turers to use through a fee free license agree­ment offered by its designer.”

Release of NeoMed’s product line with ENFit™ connec­tors (branded “NeoConnect™”) is sched­uled in advance of the California legislation’s effec­tive date of July 1, 2016 upon FDA 510(k) clear­ance of NeoMed’s low dose syringes. NeoConnect product fami­lies will be avail­able in the market­place on schedule and include ENFit-compliant or ENFit-compatible connec­tors. NeoConnect includes a complete line of phar­macy syringes, phar­macy bottle caps, the DoseMate™ oral admin­is­tra­tion tip, syringe coupler, feeding tubes, exten­sion sets, sterile enteral syringes, NeoSecure self-righting tip caps, and a feeding tube hub cleaning tool. In addi­tion, NeoMed’s “low dose solu­tion” will be avail­able in syringe sizes 0.5 mL, 1 mL, 3 mL, and 6 mL.

You can find GEDSA's update here.

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