Indications, Safety & Warnings
Read the Instructions for Use for safe and proper use of these devices. For a complete description of hazards, contraindications, side effects and precautions, see full package labeling below.
The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy. 2008T hemodialysis machine full package labeling.
The 2008K2 hemodialysis machine is designed to perform hemodialysis in hospitals and dialysis clinics. It can be used for patients suffering chronic or acute renal failure. 2008K2 hemodialysis machine full package labeling.
The DIASAFE® Plus filter is intended for the preparation of ultrapure dialysis fluid for use in hemodialysis. Attention must still be given to the chemical and microbiological quality of water and concentrate and the maintenance of supply systems (e.g. RO system, water delivery system, etc.). DIASAFE Plus filter full package labeling.
The Fresenius Medical Care OnLine Clearance Monitor is intended to be used as a module with the Fresenius Medical Care 2008 series hemodialysis machines for determination of dialysis treatment urea clearance and for access flow estimation for those patients undergoing acute or chronic hemodialysis. OnLine Clearance Monitor full package labeling available within FMCNA hemodialysis machine manual.
The CombiSet® with Twister® device is for use during hemodialysis to reverse the blood flow to and from the arterial and venous vascular access devices in order to obtain an access flow measurement. CombiSet with Twister device full package labeling.
Caution: Federal (US) law restricts these devices to sale by or on the order of a physician or other licensed practitioner.