SPICTRA

Primary DI

08906172230004

Basic UDI-DI Code

890617223CPBABFD9

Reference

M5AF

Device Types

Single use Sterile

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

No Longer On The Market

Manufacturer

MEDIHUB SCIENCETEC PRIVATE LIMITED

A sterile, porous device intended to be used in the arterial line of an extracorporeal circuit during a cardiopulmonary bypass procedure, to trap and remove potentially harmful gaseous emboli, aggregated blood constituents, and particulate matter (e.g., greater than 40 microns) to prevent them from flowing into the bloodstream and obstructing extracorporeal circulation. It is commonly referred to as a bubble trap and will typically be used for a specified length of time (e.g., 6 hours). This is a single-use device.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDR).