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 Fresenius Medical Care 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy.
2008T 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 bibag® system is used with Fresenius Medical Care three stream proportioning hemodialysis systems
equipped with the bibag module, such as the 2008T hemodialysis machine and is intended for use in bicarbonate hemodialysis for
acute and chronic renal failure. bibag bicarbonate concentrate is intended for extracorporeal bicarbonate hemodialysis according
to a physician’s prescription. bibag machine module full package labeling. bibag disposable full package labeling.
The Crit-Line® monitor III (CLM III) is a non-invasive hematocrit, oxygen saturation and percent change in blood volume monitor
used in the treatment of hemodialysis patients. In addition, the CLM III estimates access recirculation and access blood flow in
hemodialysis patients. Crit-Line monitor 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 full package labeling.
Citrasate® hemodialysate concentrate solution is formulated to be used with a three stream hemodialysis machine which is
calibrated for acid and bicarbonate dialysate concentrates.
Caution: Federal (US) law restricts these devices to sale by or on the order of a physician or other licensed practitioner.