nPulse 510(k) Clearance

Clinton, MA, August 23, 2013 --( NP Medical ( has released a new, patented, needle-free access device intended to help clinicians reduce the risk of catheter-related bloodstream infections (CRBSI) and connector reflux-induced catheter occlusions during infusion therapy. Called nPulse™, the new device has been designed to complement best clinical practices as designated by the Infusion Nurses Society(INS) and the Centers for Disease Control (CDC).

Luis J. Maseda, General Manger of NP Medical, announced that the new nPulse device has been cleared by the U. S. Food and Drug Administration for marketing in the United States. “This device is the outgrowth of the collaborative commercialization of innovative products with NP Medical’s OEM customers for more than 30 years,” said Mr. Maseda. “nPulse™ represents the pinnacle of evolution of minimal fluid displacement needle-free connectors,” he added. The nPulse™ product combines a number of clinically desirable attributes, including non-refluxing fluid displacement, high pressure rating to 325 psi, a flat swabable surface and a clear housing for direct visualization of the fluid path which facilitates clinical decision-making.

nPulse’s™ neutral fluid displacement is intended to help reduce reflux-related occlusions at both Luer connection and disconnection, with the lowest measured displacement and blood reflux of market leading valves. Its proprietary, Self-Opening Split Septum (SOSS™) works cooperatively with Luer compatible access devices to establish an aseptic connection by assuring that valve opening and closing coincides with the secure engagement of the Luer device. Unlike internal cannula devices that push through and physically drag against a split septum sealing surface, the SOSS™ design is free from physical interactions with the connecting Luer device or internal valve parts that may compromise septum seal integrity.

nPulse™ device platforms are available to OEM customers as a sterile, private label product or as a bulk, non-sterile component. “NP Medical is providing nPulse™ as a sterile, private label product in response to the sourcing needs of an evolving marketplace where our customers are looking to trusted partners to revitalize their product portfolios,” said Mr. Maseda. The collaborative commercialization of innovative, value-based products is the hallmark of NP Medical’s evolving customer engagement response to a rapidly changing healthcare landscape worldwide.

About NP Medical
NP Medical Inc. is a medical device company committed for over thirty years to the development of products that focus on patient and caregiver needs during intravenous (IV) infusion therapy and vascular access procedures. NP Medical’s goal is “to provide compelling product solutions that make quality patient care possible by improving patient outcomes and caregiver safety at an affordable cost.” Headquartered in Clinton MA, NP Medical manufactures hundreds of millions of high volume, automated, high quality IV therapy devices each year. NP Medical is a wholly owned subsidiary of Nypro Inc., a global plastics manufacturer with $ 1.2 billion annual revenues which recently has agreed to merge with Jabil Circuit, Inc., a $17 billion electronics products solutions company providing comprehensive electronics design, manufacturing and aftermarket product management services to global electronics and technology companies.
NP Medical
Nicole Klein
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