| EMDDB code |
22419
|
| Basic UDI-DI |
0690103D001SBA000RP
|
| Seadme klass |
Meditsiiniseade
|
| Medical Device Nomenclature |
|
| Risk class |
III
|
| Appliance |
-
|
| Device name (in Estonian) |
Swan-Ganz Termodilutsioonikateetrid True Size
|
| Device name (in English) |
Swan-Ganz True-Size Thermodilution Catheter
|
| Intended use (is Estonian) |
Swan-Ganzi kateetrid on kopsuarteri kateetrid, mis on mõeldud lühiajaliseks kasutamiseks vereringesüsteemi keskosas patsientidel, kes vajavad südamesisest hemodünaamilist monitooringut, vereproovide võtmist ja lahuste infundeerimist. Kui neid kasutatakse koos sobiva monitooringuplatvormi ja tarvikutega, pakuvad Swan-Ganzi kateetrid terviklikku hemodünaamilist profiili, aidates kliinikutel hinnata südame-veresoonkonna talitlust ja teha raviotsuseid.
|
| Intended use (in English) |
Swan-Ganz Catheters are pulmonary artery
catheters intended for short-term use in the
central circulatory system for patients who
require intracardiac hemodynamic monitoring,
blood sampling and infusing solutions. When
used with a compatible monitoring platform
and accessories, Swan-Ganz Catheters offers
a comprehensive hemodynamic profile to help
clinicians assess cardiovascular function and
guide treatment decisions.
|
| Type/model/article number |
132F5; 096F6P
|
| Notified body |
0123
|
| Manufacturer |
Edwards Lifesciences LLC
|
| Authorised representative |
Edwards Lifesciences GmbH
|
| In register from |
07/30/2025
|
| Entry status |
Active
|
| Device comments, keywords |
MDR
|
| Reimbursed by EHIF |
Tervisekassa soodustus puudub
|
