Device Dossier

Blood pressure transducer set

Device Dossier for Blood pressure transducer set (Blood pressure transducer set, Class IIa, sponsor ICU Medical). ARTG record, intended purpose, GMDN…

Intended purpose

A collection of devices that includes the necessary tubing, pressure transducer(s) and other items [e.g., connectors, stopcock(s), clamps and filters] used for an invasive blood pressure measurement. This set will typically connect directly to the applied invasive catheter and the transducer will provide the electrical signals for display by a patient monitoring system. This device will have physical characteristics appropriate for preserving, to the extent possible, the waveform and fidelity of the measured pressure. This is a single-use device.

TGA Public Summary