Blood Reservoir Cardiotomy 500 BRCoating

Primary DI

07898716350679

Basic UDI-DI Code

78987163562227977

Reference

622279

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 Blood Reservoir Cardiotomy 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 at Ethylene Oxide (ETO). All 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, creating a biopassive layer, 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).