Tubing Set Newborn BRCoating

Primary DI

07898716350792

Basic UDI-DI Code

78987163562230269

Reference

622302

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 Tubing Set BRCoating consists of a kit of tubes, connectors and accessories made of medical grade, non-toxic, biocompatible and non-pyrogenic materials. The product consists of the following lines: cava, arterial, pump, aspirators, serum, oxygen, recirculation, arterial filter, extensor and accessory. The tubing set is 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).