ECMOLIFE ECMO tubing set; ECMOLIFE VAS tubing set - Extracorporeal cardiopulmonary support system circuit

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Beszerezhető a:

BTC Speciality Health Pty Ltd

Osztály:

Class IIa

Gyártó:

Eurosets Srl Strada Statale 12 143, Medolla, Modena, 41036 Italy

Terápiás terület:

62085 - Extracorporeal cardiopulmonary support system circuit

Terápiás javallatok:

A complete portable assembly of noninvasive, non-powered, sterile devices intended to be used as part of an extracorporeal bypass system to provide mechanical circulatory support during extended/prolonged extracorporeal circulation [e.g., extracorporeal lung support (ECLS) or extracorporeal membrane oxygenation (ECMO)]. It includes devices such as a centrifugal pump mechanism, defoamer, heat exchanger, membrane oxygenator, and integrated tubing. It is intended to be used in conjunction with the capital components (e.g., pump drive unit, gas control unit, heating/cooling unit) and invasive components (e.g., cannulae) of the bypass. This is a single-use device.

Engedélyezési státusz:

A

Engedély dátuma:

2023-09-06