| EMDDB code |
21991
|
| Basic UDI-DI |
5019778MF001008A9
|
| Seadme klass |
Meditsiiniseade
|
| Medical Device Nomenclature |
|
| Risk class |
IIa
|
| Appliance |
-
|
| Device name (in Estonian) |
Loputustoru õhuga (10)
|
| Device name (in English) |
Irrigation Tubing with Air (10)
|
| Intended use (is Estonian) |
Loputustorud CO2/õhuga on ette nähtud kuni 24-tunniseks kasutamiseks eesmärgiga pakkuda steriilset vett loputuseks läbi abikanali (läbi loputuspumba, kui seda kasutatakse koos abikanali adapteriga) ja CO2 või õhuga insuflatsiooni ja objektiivi loputamist läbi kaheotstarbelise õhu-vee kanali (CO2 gaasiga insuflaator või õhupumba
varustus) kokkusobivatel gastronitestinaalsetel/kolonoskoopilistel endoskoopide.
|
| Intended use (in English) |
The Irrigation Tubing with CO2/air is intended for use for up to 24 hours, to provide sterile water for irrigation through the auxiliary channel (via an irrigation flushing pump when used with an Auxiliary Channel Adaptor) and CO2 or air insufflation and lens flushing through the dual air-water channel (via a CO2 Gas Insufflator or air pump supply) of compatible gastrointestinal/colonoendoscopes.
|
| Type/model/article number |
Part K10035005 MAJ-2210; Part K10035004 MAJ-2209
|
| Notified body |
2797
|
| Manufacturer |
KeyMed (Medical and Industrial Equipment) Ltd
|
| Authorised representative |
Olympus Europa SE & Co. KG
|
| In register from |
05/08/2025
|
| Entry status |
Active
|
| Device comments, keywords |
MDR
|
| Reimbursed by EHIF |
Tervisekassa soodustus puudub
|
