BEUDAMED
    14 results · 22ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    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

    Hemotherm¿ Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A dual reservoir, water re-circulating device that supplies temperature controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm or cool the blood that enters and exits a blood heat exchanger for adult, pediatric or infant patients.

    FDA Enforcement
    Class II ·Terminated·Cincinnati Sub-Zero Products LLC·February 21, 2018

    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

    Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator/Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper/hypothermia blanket under the patient to provide warming through conductive heat transfer.

    FDA Enforcement
    Class II ·Terminated·Cincinnati Sub-Zero Products LLC, a Gentherm Company·October 10, 2018

    Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The HEMOTHERM¿ Model 400CE Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator / Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper / hypothermia blanket under the patient to provide warming through conductive heat transfer.

    FDA Enforcement
    Class II ·Terminated·Cincinnati Sub-Zero Products LLC, a Gentherm Company·February 20, 2019

    Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.

    FDA Enforcement
    Class II ·Terminated·Cincinnati Sub-Zero Products LLC, a Gentherm Company·November 27, 2019

    CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.

    FDA Enforcement
    Class II ·Terminated·Cincinnati Sub-Zero Products LLC, a Gentherm Company·November 27, 2019

    Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.

    FDA Enforcement
    Class II ·Terminated·Cincinnati Sub-Zero Products LLC, a Gentherm Company·November 27, 2019

    Norm-O-Temp model 111Z

    FDA Enforcement
    Class II ·Terminated·Cincinnati Sub-Zero Products LLC, a Gentherm Company·September 11, 2019

    Norm-O-Temp model 111W

    FDA Enforcement
    Class II ·Terminated·Cincinnati Sub-Zero Products LLC, a Gentherm Company·September 11, 2019