Anesthesia Safety Products Announces FDA De Novo Clearance To Market The AirPurge™ System For Automatic Removal Of Air Bubbles In I.V. Lines
WOBURN, Mass., Sept. 23, 2014 /PRNewswire/ -- Anesthesia Safety Products LLC www.aspamerica.com (a privately held company), a designer and manufacturer of fluid management devices, has received a De Novo Class II clearance from the U.S. Food and Drug Administration (FDA) to market the new AirPurge System for the detection, automatic removal and disposal of air bubbles in intravenous (I.V.) lines during the administration of intravenous solutions, blood and blood products in the Operating Room or PACU.
The AirPurge System is a novel device that traps and disposes of Air Bubbles automatically. The System unobtrusively monitors the I.V. line attached to the device for any air bubbles which are then diverted to a built-in reservoir and are disposed of in a collection bag. The Device does not require any manual intervention, thereby minimizing interruption and delays for the medical staff. "Hospitals today are always looking to improve patient outcomes," said Ihsan Haddad, President of Anesthesia Safety Products. "This Device provides clinicians peace of mind while allowing them to focus on other matters in the OR. The Device is easy to set-up."
"It is a device that should be used routinely in the OR/PACU especially when fluid warmers are used," said Dr. Yandong Jiang of Boston, Mass. "It is extremely important to use it, as air bubbles can be potentially damaging and even more so for people with PFOs."
"The System is quite easy to set up and operate, by itself or when attached to a fluid warmer," said Maryann Barry, OR Nurse.
The Device is designed to remove air bubbles from IV lines as small as 25 micro-liters at high (600 ml/min) or low infusion rates. Patented technology activates and confirms the air purging process, and automatically reverts back to free flowing fluid within milliseconds. The AirPurge System incorporates single-use, disposable cartridges which are convenient and easy to use.
The AirPurge System can be easily integrated into an I.V. set up routine by installing it on the IV pole just below a fluid/blood warmer to capture smaller air bubbles that are typically generated during the infusate heating process. These air bubbles can be safely and automatically trapped, and disposed of without any manual intervention.
About Anesthesia Safety Products - Anesthesia Safety Products (ASP) develops and markets fluid management devices to help advance clinical and operational safety and efficiencies for the OR & PACU. The company has four (4) US Patents and other Patents Pending.
Anesthesia Safety Products, All right reserved. AirPurge is a Trademark of ASP.
Investor/Media Contact: Michael DiToro, mditoro@aspamerica.com- +1-339-222-9248
Photo - http://photos.prnewswire.com/prnh/20140923/147855
SOURCE Anesthesia Safety Products