Gambro ArtiSet HD DNL HC Blood Tubing Set

Country: Սինգապուր

language: անգլերեն

source: HSA (Health Sciences Authority)

MAH:

BAXTER HEALTHCARE (ASIA) PTE LTD

class:

Class B medical device

manufactured_by:

Gambro Dasco S.p.A.

therapeutic_area:

General Hospital

therapeutic_indication:

ArtiSet HD DNL HC is a single use sterile medical device (blood tubing system) intended to be used as an extracorporeal blood circuit for double needle hemodialysis treatment on Artis system. It can be safely connected to dialyzers, vascular accesses and various perfusion lines, under the responsibility of the physician in charge. ArtiSet HD DNL HC, when used on Artis Physio and connected to the proper accessories listed into Artis Operator’s Manual, can be used to perform Hemodiafiltration (HDF) in postdilution configuration, together with priming, bolus, rinseback, with substitution and infusion fluid on-line produced by the dialysis machine and filtered by a single use membrane designed for retention of bacteria and endotoxins. In addition, ArtiSet HD DNL HC, when connected to the dedicated accessory described in the Artis Operator‘s Manuals, can be used to perform AFB K treatments.

leaflet_short:

Device System Info:[Sterile Medical Device], The fluid pathways are sterile and non-pyrogenic. Use aseptic technique during installation of ArtiSet and throughout the hemodialysis session. ArtiSet is sterilized by radiation as indicated on the product and case labels.; Models: Artiset HD DNL HC - 955075, Artiset HD DNL HC - 955549

authorization_date:

2017-04-13