NeoMed receives FDA 510(k) clearance for its Low Dose Tip ENFit Syringe
Woodstock, GA -- (ReleaseWire) -- 08/29/2017 --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 low dose Oral Medication delivery 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.
NeoMed offers a full portfolio of neonatal catheters and kits, metric only oral syringes in both clear and amber, urinary drainage catheters, and kits, umbilical catheters, insertion kits and breast milk containers.