CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT

CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT is an FDA 510(k)-cleared medical device (K936182) manufactured by Ohmeda Medical. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 24, 1994. Regulation: 8.