An assembly of mains electricity (AC-powered) devices intended to reduce scalp hair loss associated with intravenous chemotherapy treatment by cooling the scalp to cause vasoconstriction and reduction of chemotherapy drug uptake by the follicular cells. It ...
A mains electricity (AC-powered) device intended to be used as part of a circulating-air whole-body heating/cooling system to filter, and control/regulate the temperature and flow of room air through a connected patient-applied pad (not included), for heati...
An assembly of electrically-powered devices intended to reduce scalp hair loss associated with intravenous chemotherapy treatment by cooling the scalp to cause vasoconstriction and reduction of chemotherapy drug uptake by the follicular cells. It consists o...
A mains electricity (AC-powered) device intended to be used as part of a circulating-fluid whole-body heating/cooling system to control/regulate the temperature and flow of fluid through a connected patient-applied pad (not included), for heating and altern...
A mains electricity (AC-powered) device intended to be used as part of a circulating-fluid whole-body cooling system to control/regulate the temperature and flow of fluid through a connected patient-applied pad (not included), for cooling a patient’s whole-...
A collection of flexible tubing and associated items that may include clamps, filters, and connectors, intended to be used with a peristaltic pump to deliver closed-loop circulation of a cooling solution (e.g., saline, sterile water) to a percutaneous radio...
An electrically-powered device intended to be used as part of an external circulating-air core temperature regulation system to filter, and control/regulate the temperature and flow of room air through a connected patient-applied pad (not included), to both...
A collection of sterile devices intended to be used to facilitate the function of an intravascular heating/cooling system. It typically includes tubing to connect the pump mechanism of the control unit, a heat exchange coil, a spike for insertion into the b...
A mains electricity (AC-powered) electromechanical device intended to be used in the clinical laboratory to mix two or more materials under regulated cool/cold temperatures (e.g., between 2? and 20? Celsius). It typically includes mixing and cooling modules...
A collection of sterile flexible tubing and associated items that may include clamps, filters, and connectors, used with an irrigation pump to deliver irrigation and/or cooling solution (saline) to an ablation device (e.g., an ablation catheter or a cardiac...
An assembly of devices intended to be used to pump heated and/or cooled fluid (e.g., water) through externally applied packs for localized hot and/or cold therapy to help treat a variety of adverse conditions resulting from musculoskeletal injury (e.g., pai...
An assembly of devices intended to be used to pump heated and/or cooled fluid (e.g., water) through externally applied packs for localized hot and/or cold therapy to help treat a variety of adverse conditions resulting from musculoskeletal injury (e.g., pai...
A complete portable assembly of noninvasive, non-powered devices intended to be used as part of an extracorporeal bypass system to provide short-term or prolonged (i.e., extra-surgical) mechanical circulatory life support during extracorporeal membrane oxyg...
A complete portable assembly of noninvasive, non-powered devices intended to be used as part of an extracorporeal bypass system to provide prolonged (i.e., extra-surgical) mechanical circulatory life support during extracorporeal membrane oxygenation (ECMO)...
A mains electricity (AC-powered) component of a cardiopulmonary bypass system designed to heat or cool a patient's body by extracorporeal heat exchange with the patient's perfused blood during a cardiopulmonary bypass procedure. It consists of a system to h...
An electrically-powered device intended to be used as part of an external circulating-fluid core temperature regulation system to control/regulate the temperature and flow of fluid through a connected patient-applied pad (not included), to both elevate and ...
An electrically-powered device intended to be used as part of an external circulating-fluid core temperature regulation system to control/regulate the temperature and flow of fluid through a connected patient-applied pad (not included), to lower a patient’s...
A sterile substance intended to reduce friction between components of a mechanical atherectomy system (e.g., guidewire and rotating drive shaft) during operation. It is typically a lipid-based emulsion that is pumped through a catheter during the procedure,...