FARMAKON A 2K 2,0CA G 10LT ACIDIC CONCENTRATE HEMODIALYSIS SOLUTION

Primary DI

D-8699459938297PT

Basic UDI-DI Code

B-8699459938297PT

Reference

829

Device Types

None provided

Regulation

Eu Mdd

Classification

Eu Md Class 2b

Status

On The Market

Manufacturer

KON-MED Sağlık İnşaat Turizm ve Eğitim Ltd. Şti.

"General Description: Concentrated haemodialysis solutions are indicated for the purification of blood by extracorpereal circulation by diluting with reverse osmosis water in certain ratios in dialysis machines. Intended Use: The device is intended to be used in the treatment of patients with acute chronic renal failure in all age ranges for less than 24 hours of extracorporeal bicarbonate haemodialysis. The relevant critical performance requirements and expected clinical benefits for the intended use are as follows: - Removal of sodium, potassium, calcium, magnesium, glucose and urea, which are already high in the blood values of patients with acute - chronic renal failure, and the process of balancing these values in the blood. - The process of balancing the already low sodium, potassium, calcium, magnesium, magnesium and glucose in the blood of patients with acute chronic renal failure."

Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).