Membrane Oxygenator Adult / BRV 4000 BRCoating

Primary DI

07898716350693

Basic UDI-DI Code

7898716356223787A

Reference

622378

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 Membrane Oxygenator BRCoating consists of two coupled chambers (Gas Exchanger and Heat Exchanger), being indicated for cardiopulmonary bypass procedures lasting up to 6 hours. The internal space of the gas exchanger is filled with a hydrophobic Polypropylene (PP) membrane, formed by capillaries (fibers) with a highly porous surface. The high porosity of the capillaries, associated with a uniform distribution of pores, provides the membrane with high gas transfer (diffusion) performance, desirable to meet the fundamental principle of an oxygenator: efficiency in transferring O2 to the blood and in removing carbon dioxide (CO2). The internal space of the heat exchanger is filled with thermoplastic polymer (polyester) capillaries. This thermoplastic composition, combined with the characteristics of the production process, results in non-porous capillaries, totally impermeable to blood and water, and with a high thermal transfer capacity. The Blood Reservoir Venous is made in polycarbonate, it has a spinning lid for better positioning of the connectors, safety valve, volumetric scale and siliconized polyurethane filter coated by a polyester screen, which enables the burst of bubbles and blood filtering. The product comes prepared for vacuum drainage and all the components are made with material appropriate for medical-pharmaceutical applications sterilizable in Ethylene Oxide (ETO). All the Oxygenator and Reservoir 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).