Tubing Set ECMO Adult

Primary DI

07898716350167

Basic UDI-DI Code

78987163510159039001J4

Reference

617327

Device Types

Single use Sterile

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

Braile Biomédica Indústria Comércio e Representações Ltda.

The Tubing Set ECMO consists of pre-assembled tubing lines, connectors and accessories consisting of medical grade, non-toxic, biocompatible and non-pyrogenic materials. It is used in an ECMO system. The venous line connects to a venous cannula and transports the patient's venous blood to the centrifugal pump, which pumps the blood to the oxygenator through the centrifugal line. The oxygenated blood is returned to the patient through the arterial line, which connects to the arterial cannula. All the Tubing Set ECMO surfaces in contact with blood are treated with the biocompatible coating, named BRCoating, composed of water produced by reverse osmosis, Polyethylene glycol 300 and recombinant human albumin*. This solution coats the inner surface of the product, reducing the interaction of the blood with it. *Recombinant human albumin it is not derived from Animal or Human sources.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDR).