Membrane Oxygenator Oxyprime Duo

Primary DI

07898716350594

Basic UDI-DI Code

78987163510159039004JA

Reference

618949

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 DUO consists of two coupled chambers (Gas Exchanger and Heat Exchanger), being indicated for procedures lasting up to 6 hours. The Membrane Oxygenator Oxyprime DUO has an integrated blood filter, made of polyester, developed especially for this application. The filter has an opening of 41 microns, the hydrophobic characteristics of the fabric make it difficult for air bubbles to pass through and filtering particles and clots larger than its opening. In addition to the arterial filter, the Membrane Oxygenator Oxyprime DUO has an air bubble removal geometry in the heat exchanger part, in which the extension tube must be connected to the heat exchanger's luer connector (called Bubble Trap). This geometry is responsible for eliminating large embolisms that may enter the circuit, and must remain open during the procedure. 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).