An electrically-powered device designed to deliver heated and humidified ambient air or air/oxygen to a patient during both: 1) high-flow (exceeding peak inspiratory flow) respiratory therapy; and 2) bi-level positive airway pressure (BPAP). It consists of ...
A mains electricity (AC-powered) device designed to measure several or all respiratory-gas volume and flow parameters needed to evaluate basic pulmonary function [e.g., vital capacity (VC), peak expiratory flow (PEF), forced expiratory volume (FEV), and for...
An electrically-powered device designed to measure several or all respiratory-gas volume and flow parameters needed to evaluate basic pulmonary function [e.g., vital capacity (VC), peak expiratory flow (PEF), forced expiratory volume (FEV), and forced expir...
A mobile, mains electricity (AC-powered) device designed to use laser Doppler techniques to measure the velocity of micro- and macrovascular blood circulation to assess of the extent of vascular flow restrictions [e.g., clots, stenosis, mechanical damage, a...
A component of an ultrasound renal denervation system designed to facilitate system generator-controlled flow of cooling solution (e.g., sterile water) to the system catheter during renal denervation (RDN). It includes tubing, electronic sensors and syringe...
An electrically-powered device designed to use laser speckle imaging to measure micro- and macrovascular blood circulation and to assess the extent of vascular flow and associated changes [i.e., due to clots, stenosis, vascular tone changes, mechanical dama...
An assembly of devices used for the continuous in vivo measurement and display of blood pressure and blood flow velocity in all blood vessels, including the coronary and peripheral arteries, during diagnostic and/or interventional procedures. It typically i...
A sterile, steerable, component of a haemodynamics monitoring system for the in vivo measurement of blood pressure and/or blood flow velocity in all blood vessels, including the coronary and peripheral arteries, during diagnostic and/or interventional proce...
An assembly of devices designed to measure, process, and store electronic data for the interpretation of cardiac physiological parameters received from the output of connected measuring devices (e.g., body surface or intracardiac electrocardiograph (ECG) se...
A collection of sterile devices intended to support and provide continuous physiologic organ perfusion to a donated kidney(s) during its preservation, evaluation, and transport in a kidney donor-organ preservation/transport system from the donor to the rece...
A sterile, battery-powered, hermetically-sealed pulse generator, implanted beneath the skin of the chest in a surgically-created pocket, with pacing leads in or on two chambers of the heart (right atrium and ventricle). It is intended to stimulate the chamb...
A mains electricity (AC-powered) device designed to detect air bubbles in blood returned to the body from the extracorporeal circuit of a cardiopulmonary (heart-lung) bypass system, and to detect when blood falls below acceptable levels, typically in the ve...
A sterile, battery-powered device consisting of a hermetically-sealed pulse generator, implanted beneath the skin of the chest in a surgically-created pocket, with a pacing lead in or on one chamber of the heart (right atrium or ventricle). It is intended t...
A graphic recorder designed for determining and registering volume variations in the extremities (legs/toes and/or arms/fingers) as modified by the circulation of blood through them. It typically consists of flow and/or volume sensors and transducers attach...
A dedicated computer with software that is a component of a cardiac mapping system and is used to process and store electronic information/data for the interpretation of cardiac physiological parameters received from the output of connected measuring device...
A battery-powered, hermetically-sealed pulse generator, implanted beneath the skin of the chest in a surgically-created pocket, with pacing leads in or on two chambers of the heart (right atrium and ventricle). It is intended to stimulate the chambers of an...
A battery-powered device consisting of a hermetically-sealed pulse generator, implanted beneath the skin of the chest in a surgically-created pocket, with a pacing lead in or on one chamber of the heart (right atrium or ventricle). It is intended to generat...
A device consisting of a rigid/semi-rigid transparent plastic shell that forms an enclosure over an infant's whole body, or the head only, in order to provide an enriched environment of oxygen (O2) to increase the patient's O2 uptake. It is connected to an ...
A device consisting of a rigid transparent plastic shell forming an enclosure over the head of an adult, typically to provide an enriched oxygen (O2)environment to increase the patient's O2 uptake. It is connected to an O2 source and may be used concurrentl...
A sterile device intended to be inserted into the oesophagus, orally or nasally, to continuously measure blood flow in the descending aorta by ultrasonic Doppler technology for assessment of cardiac output and/or fluid status. It is typically constructed of...
A portable, battery-powered, general-purpose device intended to measure pneumatic line flow rates and pressures (positive and negative) in order to calibrate or test a medical (e.g., anaesthesia machines, suction devices) or industrial device and is not ded...
A device intended to be inserted into the oesophagus, orally or nasally, to continuously measure blood flow in the descending aorta by ultrasonic Doppler technology for assessment of cardiac output and/or fluid status. It is typically constructed of flexibl...
A wearable, battery-powered device designed to actively promote continuous diffusion of oxygen (CDO) in a wound to help heal various types of wounds (e.g., arterial, venous, diabetic or pressure ulcers, skin grafts, burns, postoperative or traumatic wounds)...
A collection of sterile devices intended to support and provide continuous physiologic organ perfusion to a donated liver during its preservation, evaluation, and transport in a liver donor-organ preservation/transport system from the donor to the receiver ...
An application software program intended to be used as part of a thrombectomy suction assembly with electronic flow sensors and valves to manage suction (via the valves) to reduce excessive blood loss during the procedure.
A collection of sterile devices intended to support and provide continuous physiologic organ perfusion to a donated heart during its preservation, evaluation, and transport in a heart donor-organ preservation/transport system from the donor to the receiver ...
A collection of sterile devices intended to support and provide continuous physiologic organ perfusion to a donated lung(s) during its preservation, evaluation, and transport in a lung donor-organ preservation/transport system from the donor to the receiver...