Eu Mdr Eu Md Class 2b On The Market

ADVOS procedure pack

ADVOS procedure pack is combination of products packaged together and placed on the market with the purpose of being used for ADVOS hemodialysis therapy , under ADVOS hemodialysis system. The medical purpose is treatment and alleviation of diseases for a specific patient population i.e. patients diagnosed with an acute, chronic and acute-on-chronic liver failure and/or renal failure and/or acidosis.

Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
04251395500200
Basic UDI-DI Code
4251395500078W
Reference
1004207
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 2b
Status
On The Market

Additional Description

The ADVOS procedure pack is a pack that consists of following CE marked medical devices and other single use components/products: The ADVOS procedure pack is a pack that consists of following CE marked medical devices and other single use components/products: 1) Filteradapter (Part of ADVOS multi - Single use components for treatment) Article Nr. 1001816 Manufacturer: ADVITOS GmbH UDI-DI: 04251395500408 2) Filtratbeutel (Part of ADVOS multi - Single use components for treatment) Article Nr.1002560 Manufacturer ADVITOS GmbH UDI-DI: 04251395500415 3) Permeatbeutel (Part of ADVOS multi - Single use components for treatment) Article Nr. 1002105 Manufacturer: ADVITOS GmbH UDI -DI 04251395500422 4) Tubing Set ADVOS multi (VM 003334) Article Nr. 1003334 Manufacturer: F.M. S.p.A. Device class: IIb Basic UDI DI: 803325473120200201Z6 5) Desinfektionsschlauch (VM 002623) Article Nr. 1002623 Manufacturer: F.M. S.p.A. Device risk class: IIb Basic UDI DI: 803325473120200501ZM 6) Discofix Dreiwegehahn blau Article Nr. 1000073 Manufacturer: B. Braun Melsungen AG Device risk class :IIa Basic UDI DI: 40392390000007582Z 7) High Flux Dialyzer (ELISIO 19H) Article Nr.1005788 Manufacturer: NIPRO Medical Corporation Risk classification: IIb Basic UDI DI: 49684200TDA1011GM; 4968420TDHE1011XW; 4968420TDIN10113H 8) High Flux Dialyzer (ELISIO 11H) Filter Article Nr.1000098 Manufacturer: NIPRO Medical Corporation Risk classification: IIb Basic UDI DI: 49684200TDA1011GM ; 4968420TDHE1011XW; 4968420TDIN10113H

Medical Purpose

ADVOS procedure pack is combination of products packaged together and placed on the market with the purpose of being used for ADVOS hemodialysis therapy , under ADVOS hemodialysis system. The medical purpose is treatment and alleviation of diseases for a specific patient population i.e. patients diagnosed with an acute, chronic and acute-on-chronic liver failure and/or renal failure and/or acidosis.

CND Nomenclature Codes

Code Description
Z12090201 HAEMODIALYSIS EQUIPMENT

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