Cordella Heart Failure System

Primary DI

00850008997082

Basic UDI-DI Code

0850008997CHFSXT

Reference

100366-01

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 1

Status

On The Market

The Cordella Heart Failure System collects, records, and transmits physiologic data and communications from the patient at home to clinician(s) to assist with patient centered heart failure management. The system is NOT intended for active patient monitoring. The Cordella Heart Failure System (CHFS) is intended to electronically transfer communications and data from a set of medical devices in a heart failure patient’s home to a database for storage, retrieval, and display to healthcare providers. Intended use statements for the weight scale, blood pressure cuff and blood oxygen monitor are as defined by the original manufacturers.

The Cordella Heart Failure System is intended to electronically transfer communications and data from a set of medical devices in a heart failure patient’s home to a database for storage, retrieval and display to healthcare providers.

The Basic UDI-DI associated with this device has 2 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Other on-the-market devices with the same classification (Eu Md Class 1) and regulation (EU MDR).