Cincinnati Sub-Zero Products LLC — FDA Profile

Summary

Number	Class	Product	Date
Z-0629-2018	Class II	Hemotherm¿ Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A dual reserv	November 27, 2017
Z-1825-2017	Class II	Hemotherm CE, model 400CE, Heater-Cooling Device	March 9, 2017
Z-0654-2017	Class II	The Hemotherm 400CE 115v, containing power board p/n 39945	November 7, 2016
Z-1129-2015	Class II	Cold Therapy Pad - cold water circulating pad, one unit per package. The pads are used to provide	January 7, 2015
Z-1679-2014	Class II	115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients tem	January 8, 2014
Z-2209-2013	Class II	Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinna	September 3, 2013
Z-0443-2014	Class II	Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data Export Software is inten	May 15, 2013

K-Number	Device	Date
K123946	WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS	January 17, 2013
K122813	HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM	December 18, 2012
K121669	WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS)	July 3, 2012
K120081	NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS	February 17, 2012
K110104	BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM	February 4, 2011
K101148	WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS	October 1, 2010
K101589	BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS	September 20, 2010
K072621	ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR	December 13, 2007
K070339	DISPOSABLE TEMPERATURE PROBES/SENSORS AND INSTRUMENT CABLES	September 26, 2007
K942790	WARM AIR HYPERTHEERMIA SYSTEM (MODELS #130 AND #133)	January 24, 1995
K942599	WARM AIR WARMING UNIT	January 24, 1995
K910327	WARMAIR SYSTEM	May 16, 1991