PLAQUA3D - ProLUNG® 3D FOR AQUARIUS™ SYSTEM Low-flow extracorporeal CO2 removal system (LF-ECCO2R) for Aquarius™ System, Nikkiso Europe GmbH – 3 days treatment duration
by Estor SpA EUDAMED
Active
Ref PLAQUA3D
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number805604529KITPROLUNGS2 | Date18 Oct 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- ProLUNG 3D for Aquarius System - Low-flow extracorporeal CO2 partial removal system - 3 days
- Model / Reference
- PLAQUA3D
- Primary DI / UDI-DI
- 08056045290144
- Basic UDI-DI
- 805604529KITPROLUNGS2
- EMDN Code
- C03010199 Extracorporeal circulation kits - other
- Device Class
- Class IIa
- Medical Purpose
- ProLUNG® 3D CO2 removal device is intended for use in a veno-venous extracorporeal circulation system for blood CO2 partial removal in patients with acute respiratory failure. LF- ECCO2R support is an extracorporeal circulation technique used to temporarily assist the pulmonary functions in gaseous exchange of primarily carbon dioxide and partly oxygen. This technique can be applied to patients affected by acute respiratory failure not manageable with the sole aid of mechanical ventilation (pulmonary ventilator).
Manufacturer details
- EUDAMED SRN
- IT-PR-000037791
Other devices from Estor SpA
Properties
Show properties
Other properties (1)
- Sterile: No