WebMar 27, 2024 · HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM: Applicant: CINCINNATI SUB-ZERO PRODUCTS, INC. 12011 MOSTELLER RD. CINCINNATI, OH 45241 Applicant Contact: STEVEN J BERKE: Correspondent: CINCINNATI SUB-ZERO PRODUCTS, INC. 12011 MOSTELLER RD. CINCINNATI, OH 45241 Correspondent … WebJul 1, 2024 · Heater–cooler A Hemotherm model 400 CE Dual Reservoir Cooler/Heater (Cincinnati Sub-Zero Products, Inc., Cincinnati, OH, USA) was employed for the measurements of disinfection efficacy. Only one patient infection involving the presence of a Hemotherm has been identified amongst a study of 339 US Food and Drug …
Dallas Heater-Cooler Device Lawsuit Lawyers Loncar Lyon Jenkins
WebSoma Medical Parts offers OEM and replacement Cincinnati Subzero heater cooler parts and accessories. New, used and refurbished biomedical parts and accessories. … WebCincinnati Sub-Zero c/o Mr. Steven J. Berke President and CEO 12011 Mosteller Road Cincinnati, OH 45241-1528 Re: K122813 Hemnotherm®g Model 400CE Dual Reservoir Cooler/Heater System Regulation Number: 21 CFR 870.4250 Regulation Name: Controller, Temperature, Cardiopulmonary Bypass Regulatory Class: Class 11 Product Code: DWC canadian polar bear tours
Class 2 Device Recall The Hemotherm Dual Reservoir Cooler/Heater
WebDUAL RESERVOIR COOLER/HEATER MODEL 400MR OPERATION & TECHNICAL MANUAL Cincinnati Sub-Zero Products, Inc. • 12011 Mosteller Road • Cincinnati, Ohio … WebBetween January 2010 and August 2015, the FDA received 32 Medical Device Reports (MDRs) of patient infections resulting from contaminated heater-cooler devices used during various open-heart or open-chest surgical procedures. The FDA received a total … Drugwatch.com has provided reliable, trusted information about medications, … WebOPERATION MANUAL MODEL 400CE DUAL RESERVOIR COOLER/HEATER. Cincinnati Sub-Zero Products, LLC. 12011 Mosteller Road Cincinnati, Ohio 45241, U.S.A. www.cszmedical.com ... i.e. skin irritation/rash or sepsis and infection may result. Upon receipt of the HEMOTHERM, the unit should be disinfected per the WATER SYSTEM … canadian poetry contest 2023