MSA code |
17192
|
Basic UDI-DI |
|
Seadme klass |
Meditsiiniseade
|
Medical Device Nomenclature |
|
Risk class |
IIb
|
Appliance |
-
|
Device name (in Estonian) |
Provox LaryTube Fenestrated
|
Device name (in English) |
Provox LaryTube Fenestrated
|
Intended use (is Estonian) |
Provox LaryTube on seadmete Provox HME System hoidik, mis on mõeldud vokaalseks ja kopsude taastusraviks pärast täielikku larüngektoomiat. Kitseneva trahheostoomiga patsientidel kasutatakse seda ka trahhostoomi lahtihoidmiseks hingamisel. Provox LaryTube on ette nähtud kasutamiseks ainult ühel patsiendil.
|
Intended use (in English) |
The Provox LaryTube is a holder for devices in the Provox HME System intended for vocal pulmonary rehabilitation after total laryngectomy. For patients with a shrinking tracheostoma it is also used to maintain the tracheostoma for breathing. The Provox LaryTube is intended for single patient use.
|
Type/model/article number |
7637; 7638; 7640; 7641; 7643; 7644; 7646; 7647
|
Notified body |
0413
|
Manufacturer |
Atos Medical AB
|
In register from |
01/10/2022
|
Entry status |
Active
|
Reimbursed by EHIF |
Tervisekassa soodustus puudub
|