6 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH 45241 Hyper-Hypothermia device used to lower or to raise a patients temperature and/or maintain a desired patient temperature through conductive heat transfer.
FDA Enforcement
Class II
·Terminated·Cincinnati Sub-Zero Products Inc·September 25, 2013
115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or maintain a desired patient temperature through conductive heat transfer. Part number 86165.
FDA Enforcement
Class II
·Terminated·Cincinnati Sub-Zero Products Inc·June 11, 2014
Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data Export Software is intended for use in the electronic transfer of medical device data from the Blanketrol III to a computer, without controlling or altering the function or parameters of the Blanketrol III.
FDA Enforcement
Class II
·Terminated·Cincinnati Sub-Zero Products Inc·December 11, 2013
Cold Therapy Pad - cold water circulating pad, one unit per package. The pads are used to provide a patient with local cold therapy by circulating chilled water through the pad that has been positioned on the patient.
FDA Enforcement
Class II
·Terminated·Cincinnati Sub-Zero Products Inc·February 25, 2015
The Hemotherm 400CE 115v, containing power board p/n 39945
FDA Enforcement
Class II
·Terminated·Cincinnati Sub-Zero Products Inc·November 30, 2016
Hemotherm CE, model 400CE, Heater-Cooling Device
FDA Enforcement
Class II
·Terminated·Cincinnati Sub-Zero Products Inc·April 26, 2017