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Mar Cor Purification, Inc., a subsidiary of Cantel Medical Corp., announces that it has been given 510(k) clearance from the Food and Drug Administration (FDA) for MINNCARE® HD high-level disinfectant, the first water system disinfectant granted a medical device clearance for use in hemodialysis applications. MINNCARE HD disinfectant is a proprietary blend of peracetic acid and hydrogen peroxide and is completely biodegradable allowing for easy disposal and reducing environmental impact. The non-medical device version, MINNCARE® Cold Sterilant, is considered the gold standard in water system disinfection and is used daily in a variety of markets and applications.
MINNCARE HD disinfectant was developed to address the critical need for a validated water system disinfectant that is both safe and effective. After developing an effective protocol with the FDA, Mar Cor successfully conducted extensive testing to validate product performance and safety. Together with MINNCARE HD disinfectant, Mar Cor will offer validated test strips for testing strength and to verify that there are no residuals following a disinfection procedure. Both products will be available in early February 2015.
John Rickert, vice president of medical sales, notes, "MINNCARE HD disinfectant eliminates the risk of using unregulated industrial chemicals, such as chlorine bleach, in patient treatment areas. The disinfection protocol is validated, the chemistry has been proven efficacious, and accurate test strips are available to insure dosage, as well as to verify complete rinse-out of the disinfectant. The use of MINNCARE HD disinfectant in a dialysis clinic will help maintain the water system in optimum condition and make it easier for the water system operator to complete an effective disinfection."
MINNCARE® is a registered trademark of Medivators Inc. (a Cantel Medical company).
Source: Mar Cor Purification, Inc.