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 a 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.
bibag On-line Dry Bicarbonate Concentrate is used with 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. The bibag is intended for extracorporeal bicarbonate hemodialysis according to a physician’s prescription.
bibag ON-LINE BICARBONATE CONCENTRATE FULL PACKAGE LABELING
Citrasate Dry acid concentrate is indicated in the treatment of acute and chronic renal failure during the hemodialysis procedure. This concentrate is formulated to be used with a three stream hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
CITRASATE DRY ACID CONCENTRATE FULL PACKAGE LABELING
Citrasate Liquid Hemodialysate Concentrate solution is formulated to be used with a three-stream hemodialysis machine which is calibrated for acid and bicarbonate dialysate concentrates.
CITRASATE LIQUID ACID CONCENTRATE FULL PACKAGE LABELING
CombiSet blood tubing is indicated for use with a prescribed hemodialyzer. The suitability of a particular configuration is the responsibility of a physician. The Twister Access Flow Reversing Connector (AFRC) is intended 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 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 F160NRe, F180NRe, F200NRe and F250NRe dialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. Optiflux F16NRe, F18NRe and F180NR and Hemoflow F3 and F4 dialyzers are designed for single use in acute and chronic hemodialysis. The Hemoflow F40S is designed for single use in chronic hemodialysis or hemodiafiltration respectively.
DIALYZER FULL PACKAGE LABELING
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
Dissolution Unit mixes Fresenius Renal Technologies 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 in the treatment of acute and chronic renal failure during the hemodialysis procedure. This concentrate is formulated to be used with a three-stream hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
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 formulated to be used with a three-stream hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
NATURALYTE DRY BICARBONATE CONCENTRATE FULL PACKAGE LABELING
NaturaLyte Liquid Acid Concentrate is formulated to be used with a three stream hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
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 OnLine Clearance Monitor is intended to be used as a module with 2008® series hemodialysis machines for determination of dialysis treatment urea clearance and for access flow estimation for those patients undergoing acute or chronic hemodialysis.
The stay•safe PIN connectors are intended for use with a peritoneal cycler for drainage and infusion of PD solution during peritoneal dialysis exchanges. The stay•safe PIN connectors are indicated for acute and chronic peritoneal dialysis.
stay•safe FULL PACKAGE LABELING
The Versi™PD Cycler System is indicated for adult chronic peritoneal dialysis in home and clinical settings.
VERSIPD CYCLER SYSTEM FULL PACKAGE LABELING
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.
