DBI-BreathCollector Breath Bag-10

Primary DI

07640255020946

Basic UDI-DI Code

764025502TD0174A

Reference

DBI-C-1001-14

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class A

Status

Not Intended For Eu Market

Manufacturer

Effectum Medical AG

The DBI-BreathCollector breath bag is an inflatable, non-sterile, single use specimen collection device intended for use by persons instructed by an HCP that collects and stores actively exhaled breath gases. The breath gases collected with the bag of the device are intended for subsequent analysis of their composition by an analytical device (e.g. SESI-HRMS). The SESI-Adapter of the DBI-BreathCollector is intended to connect the DBI-BreathCollector breath bag to an analytical device to inject breath specimen from the breath bag into the analytical device for subsequent analysis. The adapter is intended to be used by laboratory personnel.

The Basic UDI-DI associated with this device has 4 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Other on-the-market devices with the same classification (Eu Ivd Class A) and regulation (EU IVDR).