Centrifugal Pump Safira Centriflux with BRCoating

Primary DI

07898716350587

Basic UDI-DI Code

78987163510159039003J8

Reference

616322

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 Centrifugal Pump Safira Centriflux with BRCoating consists of a body (housing) with two connectors (upper inlet and lateral outlet of blood), which contains a rotor (by magnetic coupling), responsible for generating the centrifugal force that drives the blood. The product is composed of polymeric materials and a sphere suitable for medical applications and sterilizable by Ethylene Oxide (ETO). The body and internal rotor of the Centrifugal Pump, components with greater contact with blood, are made of polycarbonate (PC) injected with a profile that allows a reduction in hemolytic traumas normally associated with ECMO procedures; the magnet is N48 Bipolar and the protective covers are made of Polyethylene. In addition, all the device 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).