Gambro ArtiSet HD DNL HC Blood Tubing Set

Singapore - English - HSA (Health Sciences Authority)

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Available from:
BAXTER HEALTHCARE (ASIA) PTE LTD
Class:
Class B medical device
Manufactured by:
Gambro Dasco S.p.A.
Therapeutic area:
General Hospital
Therapeutic indications:
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.
Product summary:
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
Authorization number:
DE0019159
Authorization date:
2017-04-13

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