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The PS 150 Hemodialyzer is intended for hemodialysis in patients with acute or chronic renal failure, when conservative therapy is judged to be inadequate.

The PS 158 Hemodialyzer consists of approximately 13,000 polysulfone hollow fibers encapsulated in polyurethane resin with an outer housing and headers made of Polycarbonate. The device is packaged in a blister package composed of Glycol modified Polyethylene Terephtalate for the bottom web, and a foil laminater for the top web. The PS 15® Hemodialyzer has two compartments, the blood compartment and the dialysate compartment, separated by the polysulfone permeable membrane and and flows from the patient access site through the tubing of the extracorporeal. system and accessories to the blood compartment of the dialyzer. From the blood compartment, undesirable substances in the blood pass through the membrane into the dialysate compartment of the dialyzer. Circulation and monitoring of dialysate into flow through the dialysate compartment is controlled by the dialysate delivery system, while the ultrafiltration controller prevents excessive loss of yeater from the patient's blood.

Altra Fluxed 200 Heinodialyzers are intended for acule or chronic Hemodialysis. Hemodiatysis is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. The Altra Flux 200 Hemodialyzer is indicated for single use or multiple use with the same patient.

The Altra Flux® 200 multiple use hemodialyzer is the Altra Flux® 200 single use device with reuse labeling. Like the Altra Flux® 200 single use device, it is used as an artificial kidney in a hemodialysis system to treat patients with acute or chronic renal failure. The blood from a patient flows through the arterial tubing of the extracorporeal blood circuit to the blood compartment of the hemodialyzer, then returns through the venous tubing of the extracorporeal blood system to the patient. The hemodialyzer has semipermeable hollow fibers which divide the device into two compartments. When the blood passes through the hollow fibers, water and toxic waste products from the blood pass through the semipermeable membrane into the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the hemodialyzer. A high permeability hemodialyzer has a semipermeable membrane that is more permeable to water than that of the conventional dialyzer. This device must be used in conjunction with a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient's blood. This highly permeable, semipermeable membrane may also permit greater loss of high molecular weight substances from the blood, compared with the conventional hemodialyzer.

Altra Nova® 200 Hemodialyzers are intended for acute or chronic Hemodialysis. Hemodialysis is indicated for patients with acute or chronic result failure when conservative therapy is judged to be inadequate. The Altra Nova 200 Hemodialyzer is indicated for single use or multiple use with the same patient.

The Altra Nova® 200 multiple use hemodialyzer is the Altra Nova® 200 single use device with reuse labeling. Like the Altra Nova® 200 single use device, it is used as an artificial kidney in a hemodialysis system to treat patients with acute or chronic renal failure. The blood from a patient flows through the arterial tubing of the extracorporeal blood circuit to the blood compartment of the hemodialyzer, then returns through the venous tubing of the extracorporeal blood system to the The hemodialyzer has semipermeable hollow fibers which divide the patient. device into two compartments. When the blood passes through the hollow fibers, water and toxic waste products from the blood pass through the semipermeable membrane into the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the hemodialyzer. A high permeability hemodialyzer has a semipermeable membrane that is more permeable to water than that of the conventional dialyzer. This device must be used in conjunction with a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient's blood. This highly permeable, semipermeable membrane may also permit greater loss of high molecular weight substances from the blood, compared with the conventional hemodialyzer.

Indications For Use of the System 1000®: - The intended use of the device is to provide hemodialysis treatments in the acute and chronic setting, including high flux hemodialysis. - The device is intended to be used by trained operators when prescribed by a physician. - The device is intended to be use in conjunction with a hollow fiber or parallel plate dialyzer. Indications for Use of the Hematocrit and Blood Volume Monitor Option: The intended use of this device is to monitor Hematocrit. Percent Blood Volume Change, Oxygen Saturation value, and Access Recirculation. - The device is intended to be used as an integrated option of the System 1000 Dialysis Delivery System. - The device is intended to be used by trained operators when prescribed by a physician. - The device is intended to be used in conjunction with the Crit-Line disposable Blood Chamber. The Blood Chamber is a non reusable device. - To provide the medical professional with a means of monitoring Hematocrit. Percent Blood Volume Change, Oxygen Saturation value, and Access Recirculation during hemodialysis treatment.

The System 1000® and AltraTouch™ 1000 devices are Single Patient Dialysis Delivery Systems for hemodialysis. The systems fulfill the following functions: - Mixes concentrate with water in the appropriate proportions to produce dialysate . - Delivers dialysate at the appropriate temperature and ionic concentration to the . dialyzer, - Removes the appropriate amount of liquid from the patient's blood . - . Along with the dialyzer and blood pump acts as a total artificial kidney. - The following option is the subject of this submission that will be implemented Note: with FDA approval. The System 1000® and AltraTouch™ 1000 Dialysis Delivery System with HCT/BV Monitor, integrates two 510(k) approved devices into one device. [System 1000%/ AltraTouch™ 1000 Dialysis Delivery System: K910215, K954987 and K955384; andCrit-Line Instrument: K924167, K950842 and K953875] This device provides the care giver with the option to monitor hematocrit, percent blood volume change, oxygen saturation value and access recirculation. The HCT/BV Monitor uses a light emitter/light detector sensor connected to a sterile disposable Blood Chamber (Crit-Line™ Blood Chamber: K924167 and K935958) in the extracorporeal blood circuit. The sensor detects various absorption and scattering characteristics exhibited by the blood. Data from the intergraded HCT/BV Monitor are communicated to the host System 1000@/AltraTouch™ 1000 machine via the serial communication port (RS232) and displayed on CRT/LCD screen of the System 1000@/AltraTouch™ 1000 machine. The HCT/BV Monitor option alerts the operator with audible and visual alarms if the patient's hematocrit is equal or exceeds the operator set hematocrit alarm limit or if the patient's blood volume is equal or lower than the operator set blood volume alarm limit.

The indications for use of the device are to provide hemodialysis treatments in the acute and chronic setting including high flux hemodialysis. - The device is intended to be used by trained operators when . prescribed by a physician. - The device is intended to be used in conjunction with a hollow fiber or parallel plate dialyzer. - The auto start option is intended to allow up to a three day . delayed start of the fluid path heat clean or rinse cycle.

The Drake Willock® System 1000® Single Patient Dialysate Delivery System is a dialysate proportioning system for hemodialysis. The system fulfills the following functions: - Mixes concentrate with water in the appropriate proportions to produce dialysate . - Delivers dialysate at the appropriate temperature and ionic concentration to the . dialyzer, - Removes the appropriate amount of liquid from the patient's blood . - Along with the dialyzer and blood pump acts as a total artificial kidney. . The following option is the subject of this submission that will be implemented with FDA approval. The fundamental modification is to provide the patient care provider with a means to delay the start of fluid path rinse or heat clean up to 3 calendar days.

Single Needle Single Lumen Dialysis is indicated for use when a single venipuncture is chosen for use in chronic or acute hemodialysis treatments.

This application is for adding the option of Single Needle Single Lumen dialysis treatment to the current System 1000® Hemodialysis Machine. Single Needle Single Lumen dialysis is performed by controlling blood flow into and out of the patient with a single needle single lumen blood access, as opposed to dialysis blood access with two needle punctures. Because of the single lumen access, the hemodialysis machine operates cyclically, i.e. part of the time blood is aspirated from the patient (arterial phase), and part of the time blood is infused to the patient (venous phase). Arterial Phase: During the arterial phase, the venous blood line is clamped, and blood is pumped via the peristaltic blood pump from the patient into the machine's extracorporeal circuit, and into (a) holding chamber(s) until a predetermined volume of blood has been accumulated. When the specified volume has been reached, the blood pump is stopped. The arterial phase is now complete. Venous Phase: During the venous phase, the venous blood line is unclamped, the arterial blood line is clamped, and the blood in the holding chamber(s) and extracorporeal circuit is returned to the patient. When the venous pressure reaches a predetermined Low Pressure Trip Point, the venous blood line is clamped. At this point, the system returns to the arterial phase, and the cycle starts again. Single Needle Single Lumen dialysis can be performed using either one peristaltic blood pump or two. (The Arterial and Venous phases described above apply to either system configuration). In systems using two pumps, the second pump returns the blood to the patient (Venous Phase). In systems using one pump, the pressure difference between the venous drip chamber and the patient causes the blood to return to the patient. Single Needle Single Lumen dialysis (with systems using either one peristaltic pump or two) can be performed using either one line clamp or two. (The Arterial and Venous phases described above apply to either system configuration.) The second (arterial) clamp is required only when a blood line with an arterial drip chamber is used.

To provide hemodialysis treatment to patients with acute or chronic renal failure.

A hemodialysis delivery system which will provide dialysate at the prescribed temperature and ionic concentration to be used for hemodialysis treatment. It has the ability to monitor machine, dialysate, and blood circuit functions during dialysis. The machine treatment parameters are displayed on a Liquid Crystal Display monitor screen. The operator controls is done through a interactive touch screen.