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Smiths Medical Asd, Inc.
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THERA-HEAT HEATED HUMIDIFIER AND ADULT DUAL AND SINGLE LIMB HEATED WIRE VENTILATOR BREATHING CIRCUITS is an FDA 510(k)-cleared medical device (K071958) manufactured by Smiths Medical Asd, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 20, 2007. Regulation: 8.