Profile: Nxstage Medical, Inc. specializes in bloodlines, needles and products for in-center dialysis and pheresis applications. Our NxStage System One™ helps make daily and home therapy more accessible. It is the portable hemodialysis system cleared for home use. The System One is designed from the ground up to provide the simplicity, flexibility and portability to make daily and home dialysis a practical reality, without compromising safety.
FDA Registration Number: 3009141079
27 Products/Services (Click for related suppliers)
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| • Analytical-Grade Water Purification Systems |
| • Anti-Regurgitation Valve with Blood Tubing Set (FDA Code: FJK / 876.5820) A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer. |
| • Dialysis Transducer Protector (FDA Code: FIB / 876.5820) |
| • Fistula Needle (FDA Code: FIE / 876.5540) A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices. |
| • Hemodialysis Blood Circuit Accessories (FDA Code: KOC / 876.5820) |
| • High Permeability with/without Sealed Dialysate System (FDA Code: KDI / 876.5860) A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices: |
| • Lab Water Purification Systems |
| • Laboratory Grade Water Purification Systems |
| • Liquid Hemodialysis Dialysate Concentrate Solution (FDA Code: KPO / 876.5820) |
| • Millipore Water Purification Systems |
| • Proportioning Subsystem (FDA Code: FKR / 876.5820) |
| • Remote Accessories Hemodialysis System (FDA Code: MON / 876.5820) |
| • Single Lumen Hypodermic Needle (FDA Code: FMI / 880.5570) A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set. |
| • Single Patient Dialysate Delivery System (FDA Code: FKP / 876.5820) |
| • Solar Powered Water Purification Systems |
| • Thermal Infusion Fluid Warmer (FDA Code: LGZ / 880.5725) |
| • Ultrapure Grade Water Purification Systems |
| • Ultrapure Grade Water Purification Systems - 5L per day |
| • Water Purification Subsystem (FDA Code: FIP / 876.5665) A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system. |
| • Water Purification System With Pump |
| • Water Purification Systems |
| • Water Purification Systems (Analytical Chemistry) |
| • Water Purification Systems (General) |
| • Water Purification Systems (Life Science) |
| • Water Purification Systems (Molecular Biology) |
| • Water Purification Systems (Ultratrace Analysis) |
| • Water Purification Systems For Ultrapure |