Sorin Group Deutschland GmbH — FDA Profile

Summary

Number	Class	Product	Date
Z-0401-2018	Class II	CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the pump control panel. I	October 30, 2017
Z-0857-2014	Class II	CP5 centrifugal pump system Product Usage: The Stockert S5/ Sorin C5 System is intended to be us	December 4, 2013
Z-0856-2014	Class II	S5/C5 Heart-lung machine Product Usage: The StOckert S5/ Sorin C5 System is intended to be used	December 4, 2013
Z-0142-2014	Class II	S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert S5 System	September 24, 2013

K-Number	Device	Date
K170460	Sorin Connect	June 8, 2017
K131553	XTRA	March 21, 2014
K140012	SORIN FLEXTHERM	January 31, 2014
K131816	SORIN CONNECT DATA MANAGEMENT SYSTEM	July 23, 2013
K112225	SORIN CENTRIFUGAL PUMP 5 (CP5)	September 20, 2011
K103468	STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS)	January 20, 2011
K103762	SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLE	January 20, 2011
K103469	STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05	January 18, 2011
K103168	B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD)	January 6, 2011
K101046	STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM	December 9, 2010
K093882	SORIN C5 SYSTEM MODEL 58-00-00	January 15, 2010
K092463	SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM	November 5, 2009
K091008	STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55	July 15, 2009
K091007	AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05	July 2, 2009
K082344	STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO)	December 17, 2008
K080832	STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER	July 30, 2008
K071318	MODIFICATION TO: STOCKERT S5 SYSTEM	July 6, 2007
K062396	MODIFICATION TO STOCKERT S5 SYSTEM	September 28, 2006
K052601	STOCKERT HEATER-COOLER SYSTEM 3T	June 6, 2006
K060053	STOCKERT S5 SYSTEM	June 2, 2006