Membrane Oxygenator Oxyprime ECMO Adult

Primary DI

07898716350020

Basic UDI-DI Code

78987163510159030111GD

Reference

617320

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 Oxyprime ECMO Adult consists of two coupled chambers (Gas Exchanger and Heat Exchanger), being indicated for long-term procedure. The internal space of the gas exchanger is filled with a Polymethylpentene (PMP) 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 capillaries of thermoplastic polymer (polyester). This thermoplastic composition, combined with the characteristics of the production process, results in non-porous capillaries, totally impermeable to blood and water, and with high heat transfer capacity. All the Oxygenator surfaces in contact with the 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).