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Terviseamet
FOR VISUALLY IMPAIRED

Medical device

MSA code 16971
Basic UDI-DI
Seadme klass Meditsiiniseade
Medical Device Nomenclature
Risk class IIb
Appliance -
Device name (in Estonian) CADD-Solis pumba komplekt
Device name (in English) Pump Kit, CADD-Solis
Intended use (is Estonian) CADD®-Solis ambulatoorne infusioonipump on näidustatud intravenoosseks, arteriaalseks, subkutaanseks, intraperitoneaalseks, närvide vahetus läheduses, intraoperatiivsesse kohta (pehmete kudede, kehaõõne/kirurgilise haava koht), epiduraalsesse ruumi või subarahnoidaalse ruumi infusiooniks. . Pump on mõeldud teraapiateks, mis nõuavad pidevat infusioonikiirust ja/või vahelduvat boolust, ja/või patsiendi kontrollitud vajadusdoosidega.
Intended use (in English) The CADD®-Solis Ambulatory Infusion Pump is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/surgical wound site), epidural space, or subarachnoid space infusion. The pump is intended for therapies that require a continuous rate of infusion, and/or an intermittent bolus, and/or with patient-controlled demand doses.
Type/model/article number 21-2111-0402-51L
Notified body 2797
Manufacturer Smiths Medical ASD, Inc.
Authorised representative Smiths Medical Czech Respublica a.s.
In register from 10/14/2021
Entry status Active
Reimbursed by EHIF Tervisekassa soodustus puudub
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