Middleburg Heights, OH -- Codonics Inc. received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its SLS Safe Label System on February 7, 2011. Codonics SLS is first in its class of advanced syringe labeling patient safety devices and cleared to market per 510(k) K101439 as a Class II device. Codonics SLS is a complete solution for safe, compliant, fast labeling of medication in the operating room, or anywhere syringes are prepared. The system ensures that syringe labels are fully compliant with the National Safety Patient Goals of The Joint Commission Standards (TJC) and the American Society of Anesthesiologists (ASA) Guidelines for medication labeling.
"The SLS Safe Label System will help to improve healthcare and drive costs down by improving patient safety and workflow efficiencies," said Gary Enos, Vice President Business and Technology Integration, Codonics. "The Safe Label System automates the workflow so that compliant labels are printed while the syringe is being prepared, providing clinicians with IV medication safety checks."
The Codonics Safe Label System is based upon the SmartLabels technology licensed from Massachusetts General Hospital. The system was developed by anesthesiologists at Massachusetts General Hospital to prevent intravenous medication errors via bar-code assisted medication labeling. When integrated with the Anesthesia Information Management System (AIMS), SLS data can tie directly to the electronic patient record that includes several additional safety features. At the 2008 ASA Annual Meeting, the SmartLabel system was awarded the Ellison C. Pierce Award from the Anesthesia Patient Safety Foundation for best scientific exhibit in patient safety.
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The SLS system was honored at the 2011 NorTech Innovation Awards on February 24. Each year, the NorTech Innovation Awards honor Northeast Ohio's latest technological breakthroughs that have or demonstrate the ability to positively impact industries and markets along with its' local economy through job creation, attraction of capital investment, and overall business growth.
About Codonics Inc.
Headquartered in Middleburg Heights, Ohio, Codonics designs, manufactures, sells and supports medical imaging and information management devices. A global leader in image documentation solutions, Codonics products are widely used in the medical industry with tens of thousands of installations worldwide. Codonics mission is to improve healthcare for patients and providers and lower costs through improved safety and efficiencies. Ideal applications in medical imaging include PACS, MRI, CT, CR/DR, Oncology, Cardiology, Fluoroscopy, Mammography, Molecular Imaging and PET, PET/CT, Orthopaedics, Radiation Therapy, Ultrasound, Angiography, Mobile and Military. Codonics operating room products modernize workflow and enhance patient safety, and thus are integral to the evolution of electronic patient records.
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