Q-FLO(TM) Closed System Male Luer Received 510(k) Marketing Clearance by the US FDA
LA JOLLA, Calif., July 18, 2012 /PRNewswire/ — I3 Corporation announced today that the Q-FLO(TM) Male Luer System received 510(k) Marketing Clearance by the US FDA.
The Q-FLO(TM) is a novel male luer lock mechanism for closed system medication transport and delivery. The Q-FLO(TM) offers unique features and benefits for medication delivery, which include: a) a closed, no drop, valved connection system preventing drips and spillage of drugs, b) convenient locking mechanism allowing for a fast and easy mechanism to establish a patent connection; c) first ever Visual Indicator that provides for a clear, color coded, visual confirmation of the status of the connection; and d) complete swabability at the top of the connector, with flat smooth surface allowing for true friction disinfection during pre-access swabbing.
The Q-FLO(TM) was cleared by the FDA with a very broad intended use. In its letter of June 8th, the FDA has cleared Q-FLO(TM) for “use by healthcare professionals for connection with standard open female luers when reconstituting, dispensing/transferring, administering, and disposal of potentially hazardous fluids, such as chemotherapy, radioactive isotopes, and blood products, as well as non-hazardous fluids.”
“The Q-FLO(TM) represents a significant advance in the state of the art of closed system devices, offering improved safety and convenience for healthcare workers administering cytotoxic drugs to patients around the world,” stated Babak Nemati, Ph.D., President & CEO of I3. “We are proud of the accomplishments of our design and development team, and the FDA clearance represents a key milestone in the history of our company. We will now focus on securing commercial partners for the launch of the Q-FLO(TM) internationally.”
In the current hospital environment, thousands of pharmacists, nurses, physicians and other caregivers may encounter a serious threat to their own physical and reproductive health, on a daily basis, through inadvertent exposure to cytotoxic drugs, such as chemotherapy, antivirals, antibiotics, hormones, nuclear medicine drug.
About I3 Corporation (www.infusioninnovations.net)
I3 is a La Jolla, California, based emerging medical device company focused on the design and development of innovative products for improved hospital safety. Founded in 2006, I3 has a strong proprietary portfolio of products. The fundamental driving philosophy behind our products is bringing key engineering innovation to improve safety, ease of use, and functionality of established hospital based products.
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SOURCE I3 Corporation