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| EMDDB code |
21993
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| Basic UDI-DI |
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| Seadme klass |
Meditsiiniseade
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| Medical Device Nomenclature |
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| Risk class |
IIb
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| Appliance |
-
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| Device name (in Estonian) |
BLUselect® Trahheostoomi kanüül, Soft-Seal® mansetiga, fenestreeritud
|
| Device name (in English) |
BLUselect® Tracheostomy Tube, Soft-Seal® Cuff, Fenestrated
|
| Intended use (is Estonian) |
BLUselect® trahheostoomi kanüül on mõeldud patsientidele, kes vajavad trauma või tervisliku seisundi tõttu kunstlikku hingamisteed. Maksimaalne soovitatav kasutusaeg on 29 päeva.
|
| Intended use (in English) |
BLUselect® Tracheostomy Tube is for patients that require an artificial airway due to trauma or medical condition. Maximum recommended period of use is 29 days.
|
| Type/model/article number |
101/812/060, 101/812/070, 101/812/075, 101/812/080, 101/812/085, 101/812/090, 101/812/100
|
| Notified body |
2797
|
| Manufacturer |
Smiths Medical ASD, Inc.
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| Authorised representative |
Smiths Medical Czech Respublica a.s.
|
| In register from |
05/09/2025
|
| Entry status |
Active
|
| Device comments, keywords |
MDD
|
| Reimbursed by EHIF |
Tervisekassa soodustus puudub
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