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 2008K@home™ machine is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K@home machine is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician.
2008K@HOME HEMODIALYSIS MACHINE FULL PACKAGE LABELING
The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare facility.
2008T HEMODIALYSIS MACHINE FULL PACKAGE LABELING
The 2008T BlueStar™ hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare facility.
Additional therapy options for patients receiving hemodialysis include: Isolated Ultrafiltration, Sustained Low Efficiency Dialysis (SLED), and low volume hemodialysis (patients weighing ≥ 20kg and ≤ 40 kg). This machine accommodates the use of both low flux and high flux dialyzers. The SLED therapy option is not to be used for patients weighing ≤ 40 kg. The 2008T BlueStar hemodialysis machine is not to be used for plasma replacement therapies, for patients weighing less than 20 kg, or for renal therapies using substitution fluid.
2008T BLUESTAR HEMODIALYSIS MACHINE FULL PACKAGE LABELING
The AquaBplus™ Water Purification Systems are reverse osmosis units intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or other related therapies. These devices are intended to be a component in a complete water purification system and are not complete water treatment systems. Each reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (US) standards.
The AquaC UNO H™ Portable Water Purification System is a reverse osmosis unit intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. The AquaC UNO H can be connected to hemodialysis equipment used in hospitals, clinics, and in-home environments. This device is intended to be a component in a complete water purification system, and is not a complete water treatment system. The reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI and FDA-recognized US standards.
The bibag® System is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. The bibag System is intended to be used as one component in the preparation of dialysate according to a physician’s prescription in a 3-stream proportioning hemodialysis machine equipped with the bibag module.
bibag ON-LINE BICARBONATE CONCENTRATE FULL PACKAGE LABELING
Citrasate® Dry Acid Concentrate is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. Citrasate Dry Acid Concentrate is intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician's prescription.
CITRASATE DRY ACID CONCENTRATE FULL PACKAGE LABELING
Citrasate Liquid Acid Concentrate is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. Citrasate Liquid Acid Concentrate is intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician's prescription.
CITRASATE LIQUID ACID CONCENTRATE FULL PACKAGE LABELING
Crit-Line® Technology is designed to non-invasively measure hematocrit, oxygen saturation and percent change in blood volume. The technology employs a sensor clip which emits multiple wavelengths of light to trans-illuminate the blood in the Crit-Line blood chamber. The differences in light absorption between blood constituents allow for the identification and measurement of the hematocrit. The measurement of hematocrit, percent change in blood volume and oxygen saturation in real-time during hemodialysis is intended to provide a more effective treatment for both the dialysis patient and the clinician. Based on the data that the monitor provides, the clinician/nurse, under physician direction, can intervene (i.e., by increasing or decreasing the rate at which fluid is removed from the blood) to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common complications of dialysis which include nausea, cramping and vomiting. The technology is available as a stand-alone device (Crit-Line III Monitor, Crit-Line IV Monitor) or as an optional module on the 2008T hemodialysis machine (CLiC™ device).
CRIT-LINE CLIP MONITOR FULL PACKAGE LABELING
Optiflux® Dialyzers are intended for patients with acute kidney injury or chronic kidney disease when conservative therapy is judged to be inadequate.
The Hemoflow F3 and F4 dialyzers are intended for hemodialysis of patients, including pediatric patients, with acute or chronic renal failure when conservative therapy is judged to be inadequate. Consider body and dialyzer surface area, blood flow, body weight, and extracorporeal blood volume when selecting dialyzers for use with pediatric patients.
DIALYZER FULL PACKAGE LABELING
The DIASAFE®plusUS is intended for the preparation of ultrapure dialysate and sterile, non-pyrogenic substitution fluid from pretreated water and is not intended to provide primary purification. Attention must still be given to the chemical and microbiological quality of water and concentrates and the maintenance of supply systems (e.g. RO system, central delivery system).
The microbiological quality (microbial count [CFU/mL] and endotoxin measurement [EU/mL]) of the incoming water should be < 200 CFU/mL and < 2 EU/mL, respectively.
The DIASAFEplusUS can only be used with Fresenius Medical Care dialysis machines fitted for use with DIASAFEplusUS.
DIASAFE PLUS FILTER FULL PACKAGE LABELING
The Fresenius Medical Care Dry Acid Dissolution Unit mixes Fresenius Medical Care distributed dry acid concentrate products with hemodialysis quality water. The resulting liquid acid concentrates are intended for use in three-stream hemodialysis machines calibrated for acid and bicarbonate concentrates.
DISSOLUTION UNIT FULL PACKAGE LABELING
GranuFlo® Dry Acid Concentrate is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. GranuFlo Dry Acid Concentrate is intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician's prescription.
GRANUFLO DRY ACID CONCENTRATE FULL PACKAGE LABELING
The Liberty® Select cycler is indicated for acute and chronic peritoneal dialysis.
LIBERTY SELECT CYCLER FULL PACKAGE LABELING
NaturaLyte® Dry Bicarbonate Concentrate is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. NaturaLyte Dry Bicarbonate Concentrate is intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician's prescription.
NATURALYTE DRY BICARBONATE CONCENTRATE FULL PACKAGE LABELING
NaturaLyte Liquid Acid Concentrate is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. NaturaLyte Liquid Acid Concentrate is intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician's prescription.
NATURALYTE LIQUID ACID CONCENTRATE FULL PACKAGE LABELING
The Novalung® System is indicated for long-term (>6 hours) respiratory/cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blood in adults with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. These may include:
- Failure to wean from cardiopulmonary bypass following cardiac surgery in adult patients
- ECMO-assisted cardiopulmonary resuscitation in adults
The NxStage® System One™ is indicated for the treatment of acute and chronic renal failure, or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility. The NxStage System One is also indicated for Therapeutic Plasma Exchange in a clinical environment. All treatments must be administered under physician’s prescription, and must be observed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.
The WetAlert™ wireless wetness detector is indicated for use with the 2008K@home hemodialysis machine and is an optional accessory to aid in the detection of blood and water leaks during hemodialysis. Home hemodialysis using the detector must be observed by a trained and qualified person as prescribed by their physician.
Caution: Frequency, duration, and parameters of treatment are to be determined by the prescribing physician.
DELFLEX® is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis.
IMPORTANT SAFETY INFORMATION
- Intended for intraperitoneal administration only;
- Not for intravenous or intra-arterial administration;
- Use aseptic technique throughout the procedure;
- Monitor routinely for electrolyte, fluid, and nutrition imbalances;
- Monitor for signs of peritonitis or overfill;
- Inspect the drained fluid for fibrin or cloudiness;
- Ensure that there is no leakage around the catheter;
- Solution-related adverse reactions may include peritonitis, catheter site infection, electrolyte and fluid imbalances, hypovolemia, hypervolemia, hypertension, disequilibrium syndrome, muscle cramping, abdominal pain, abdominal distension, and abdominal discomfort.
DELFLEX is available by prescription only. For additional Safety Information, please see full Prescribing Information.
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Medical Care North America at 1-800-323-5188. You are encouraged to report negative side effects of prescription drugs to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Visit MedWatch or call 1-800- FDA-1088.
