Anesthesia Safety Products (ASP) has obtained De Novo Class II clearance from the US Food and Drug Administration (FDA) for its new AirPurge System.
The approval will allow the company to market the system, which will be used in the detection, automatic removal and disposal of air bubbles in intravenous (IV) lines during the administration of intravenous solutions, blood and blood products in the operating room or PACU.
The device has been developed to remove air bubbles from IV lines as small as 25 micro-liters at high (600ml/min) or low infusion rates.
According to the company, the patented technology activates and confirms the air purging process, and automatically reverts back to free flowing fluid within milliseconds.
Anesthesia Safety Products president Ihsan Hadd said the hospitals are always looking to improve patient outcomes.
"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," Hadd added.
The company, which produces fluid management devices, has four US patents and other patents pending.
Image: The AirPurge system can be used by itself or with Fluid Warmers. Photo: courtesy of PRNewsFoto/Anesthesia Safety Products.