DBI-BreathCollector Starter Kit-10

Primary DI

07640255020809

Basic UDI-DI Code

764025502TD0174A

Reference

DBI-C-1001-03

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 is a kit that comes in different configurations. It is intende for single use. The breath bag (1l) is the essential part of the device. A mouthpiece is attached to the bag spout containing a check valve that prevents the collected breath gases from escaping. Instead of the mouthpiece, a mask (22 mm tapered connection complying with ISO 5356) and possibly appropriate adapters can be attached to the breath bag. The patient will fill the bag with their breath under the supervision of an HCP. Once the breath sample is collected, the mouthpiece is disconnected and disposed. The system is then closed airtight with the sealing cap. The airtight system is then sent to the analysis laboratory in a shipping box. To open and connect the breath bag to the analysis device, a SESI-Aadapter has to be used which punctures the sealing cap and opens the check valve allowing the breath sample to be injected into the analysis device. The collected breath gases will be used for a qualitative analysis of exhaled drug metabolites and other components in the breath gases.

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).