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This device is indicated for hemodialysis prescribed by physicians for adult patients with acute and chronic renal failure, treated in hospitals and dialysis clinics by qualified operators. This device is not indicated for pediatric patients. It is not for home use. This device is made up of disposable bloodlines intended to provide extracorporeal access to a patient's blood during hemodialysis. It is the responsibility of the physician or other licensed practitioner to ensure compatibility with the available configurations.

The BLOOD TUBING LINES FOR HEMODIALYSIS AL series (Sterilized by Ethylene Oxide) includes arterial and venous dialysis blood tubing. The devices are packaged together for convenient use during hemodialysis procedures. They are manufactured for application with the DBB-06 PRO Hemodialysis Delivery System. The components of the device include tubing, drip chambers, infusion tubing, pressure monitoring lines, ports, clamps and filters which are used to pump blood, retain and capture blood debris, infuse medications or fluids, sample blood as well as monitor pressure. The devices are packaged sterile and labeled for single use only. These devices cannot be cleaned and reused. They are restricted for sale by or on the order of a physician. The BLOOD TUBING LINES FOR HEMODIALYSIS C18 series is one part of a blood tubing lines for hemodialysis. The devices are packaged together for convenient use during hemodialysis procedures. They are manufactured for application with the DBB-06 PRO Hemodialysis Delivery System. The devices are packaged sterile and labeled for single use only. These devices cannot be cleaned or reused. They are restricted for sale by or on the order of a physician.

This device is indicated for hemodialysis prescribed by physicians for adult patients with acute and chronic renal failure, treated in hospitals and dialysis clinics by qualified operators. This device is not indicated for pediatric patients. It is not for home use. This device is made up of disposable bloodlines intended to provide extracorporeal access to a patient's blood during hemodialysis. It is the responsibility of the physician or other licensed practitioner to ensure compatibility with the available configurations.

The BLOOD TUBING LINES FOR HEMODIALYSIS AL series (Sterilized by Steam) includes arterial and venous dialysis blood tubing. The devices are packaged together for convenient use during hemodialysis procedures. They are manufactured for application with the DBB-06 PRO Hemodialysis Delivery System. The components of the device include tubing, drip chambers, infusion tubing, pressure monitoring lines, ports, clamps and filters which are used to pump blood, retain and capture blood debris, infuse medications or fluids, sample blood as well as monitor pressure. The devices are packaged sterile and labeled for single use only. These devices cannot be cleaned and reused. They are restricted for sale by or on the order of a physician. The BLOOD TUBING LINES FOR HEMODIALYSIS C18 series is one part of a blood tubing lines for hemodialysis. The devices are packaged together for convenient use during hemodialysis procedures. They are manufactured for application with the DBB-06 PRO Hemodialysis Delivery System. The devices are packaged sterile and labeled for single use only. These devices cannot be cleaned or reused. They are restricted for sale by or on the order of a physician.

This device is indicated for hemodialysis prescribed by physicians for adult patients with acute and chronic renal failure, treated in hospitals and dialysis clinics by qualified operators. This device is not indicated for pediatric patients. It is not for home use. This device is made up of disposable bloodlines intended to provide extracorporeal access to a patient's blood during hemodialysis. It is the responsibility of the physician or other licensed practitioner to ensure compatibility with the available configurations.

The BLOOD TUBING LINES FOR HEMODIALYSIS AV06C-E includes arterial and venous dialysis blood tubing. The devices are packaged together for convenient use during hemodialysis procedures. They are manufactured for application with the DBB-06 Hemodialysis Delivery System. The components of the device include tubing, drip chambers, infusion tubing, pressure monitoring lines, ports, clamps and filters which are used to pump blood, retain and capture blood debris, infuse medications or fluids, sample blood as well as monitor pressure. The devices are packaged sterile and labeled for single use only. These devices cannot be cleaned and reused. They are restricted for sale by or on the order of a physician.

This device is indicated for hemodialysis prescribed by physicians for adult patients with acute and chronic renal failure, treated in hospitals and dialysis clinics by qualified operators. This device is not indicated for pediatric patients. It is not for home use. This device is made up of disposable bloodlines intended to provide extracorporeal access to a patient's blood during hemodialysis. It is the responsibility of the physician or other licensed practitioner to ensure compatibility with the available configurations.

The BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) includes arterial and venous dialysis blood tubing. The devices are packaged together for convenient use during hemodialysis procedures. They are manufactured for application with the DBB-06 Hemodialysis Delivery System. The components of the device include tubing, drip chambers, infusion tubing, pressure monitoring lines, ports, clamps and filters which are used to pump blood, retain and capture blood debris, infuse medications or fluids, sample blood as well as monitor pressure. The devices are packaged sterile and labeled for single use only. These devices cannot be cleaned or reused. They are restricted for sale by or on the order of a physician. The BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series is one part of a blood tubing lines device for hemodialysis. The devices are packaged together for convenient use during hemodialysis procedures. They are manufactured for application with the DBB-06 Hemodialysis Delivery System. The devices are packaged sterile and labeled for single use only. These devices cannot be cleaned or reused. They are restricted for sale by or on the order of a physician.

The Blood Tubing Set is a sterile, single use, disposable indicated for use with a prescribed hemodialyzer. The suitability of a particular bloodline/hemodialyzer configuration is the responsibility of the physician. The Blood Tubing Set is intended for acute and chronic hemodialysis therapy. The Blood Tubing Set is intended to be used with Fresenius Medical Care 2008® Series K, K2 and T Hemodialysis Machines equipped with Crit-Line hardware. The Crit-Line Blood Chamber is an optical cuvette designed for use with the Crit-Line monitor's sensor clip during acute and chronic hemodialysis therapy to non-invasively measure hematocrit, percent change in blood volume, and oxygen saturation.

The CombiSet SMARTECH Hemodialysis Blood Tubing Sets (hereinafter referred to as "CombiSet SMARTECH Bloodlines") are the subject of this 510(k) and are available in two (2) configurations: - CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and ● Integrated Crit-Line Technology (hereinafter referred to as the "Standard bloodline") - . CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, no Heparin Line (hereinafter referred to as the "No heparin line") The CombiSet SMARTECH Bloodlines are single-use, ethylene oxide (EO) sterilized blood tubing sets. The CombiSet SMARTECH Bloodlines are part of the extracorporeal hemodialysis circuit. During hemodialysis, the extracorporeal circuit transports arterial blood from the patient's arterial access (e.g., fistula or catheter), through a hemodialyzer, and back to the patient's venous access. When the CombiSet SMARTECH Bloodlines are used with the Crit-Line Sensing System (which includes the Crit-Line Sensor Clip), the proposed devices will provide a clear viewing surface for the Crit-Line Sensor Clip to transmit light through the blood.

CAREline Twister: The blood tubing set is indicated for use with a prescribed hemodialyzer. The suitability of a particular bloodline/ hemodialyzer configuration is the responsibility of the physician. The Blood Tubing Set is intended for acute and chronic hemodialysis therapy. The Fresenius Access Flow Reversing Connector (AFRC) is for use during hemodialysis to reverse the blood flow to and from the arterial and venous vascular access devices during hemodialysis in order to obtain an access flow measurement. The AFRC facilitates the test procedure by eliminating the need to disconnect bloodlines during the test procedure. Blood Tubing Set is intended to be used with the Fresenus Medical Care 2008® Series, K, K2 and T Hemodialysis Machines. CAREline Standard: The blood tubing set is indicated for use with a prescribed hemodialyzer. The suitability of a particular bloodline/ hemodialyzer configuration is the resonsiblity of the physician. The Blood Tubing Set is intended for acute and chronic hemodialysis therapy. Blood Tubing Set is intended to be used with the Fresenus Medical Care 2008® Series, K, K.2 and T Hemodialysis Machines.

The CAREline bloodlines are intended for use in acute and chronic hemodialysis therapy. The bloodline is part of the hemodialysis extracorporeal circuit, which transports arterial blood from the patient's arterial access (e.g., fistula or catheter) through a hemodialyzer and back to the patient's venous access.

The CRIT-LINE Clip (CLiC) Blood Chamber is a sterile, single use, disposable, optical cuvette designed for use with the CLiC Monitor's sensor clip during acute and chronic hemodialysis therapy to non-invasively measure hematocrit, percent change in blood volume, and oxygen saturation. The blood chamber is connected between the arterial bloodline and the dialyzer within the extracorporeal circuit during hemodialysis treatment.

Like the predicate, the modified CRIT LINE Clip (CLiC) Blood Chamber is a non-invasive, disposable, optical cuvette with transparent lenses designed to connect between the arterial bloodline and the dialyzer in the extracorporeal circuit during hemodialysis treatment. The chamber's two (2) clear polycarbonate viewing lenses serve to secure the CLiC Monitor's sensor clip and provide a uniform cross section, allowing a clear view of the blood passage for the CLiC Monitor to transmit light through the blood. The CLiC Monitor uses the principle of light absorption and scattering to measure oxygen saturation (O2 SAT) and hematocrit (HCT) levels in the blood. The proposed device is the same as the predicate. CRIT LINE Clip (CLiC) Blood Chamber (K141281) with a change only to the internal geometry (taper) of the dialyzer connector (also referred to as the 'female DIN connector').

The Crit-Line IV System is used to non-invasively to measure hematocrit, oxygen saturation and percent change in blood volume. The Crit-Line Clip (CLiC) measures hematocrit, percent change in blood volume and oxygen saturation in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the dial. Based on the data that the monitor provides, the clinician/nurse, under physician direction, intervenes (i.e. increases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient experiencing the common symptoms of dialysis which include nausea, cramping and vomiting.

The intended use of the Crit-Line IV System is as a continuous real-time blood monitoring system for displaying information measured by the CLiC sensor, including hematocrit, oxygen saturation, and percent change in blood volume. The Crit-Line IV System is comprised of the Crit-Line IV monitor (the subject of this submission), the Crit-Line Clip (CLiC) sensor, and the Crit-Line Clip Blood Chamber. The touchscreen interface and display of the Crit-Line IV monitor is used with the hardware and software of the CLiC sensor, which is a separate component of the Crit-Line Clip (CLiC) Monitor, K121599. Information displayed on the Crit-Line IV monitor may be viewed real-time during a dialysis treatment. There are additional display features incorporated into the Crit-Line IV System, which are similar to that of the Crit-Line III system (K972470) and the 2008T Hemodialysis Machine with (optional) CLiC (K131908). For this reason, the Crit-Line Clip Monitor (CLiC: K121599), is the predominant predicate and the 2008T Hemodialysis Machine with (optional) CLiC (K131908) and the Crit-Line III (K972470) are reference predicate devices.

The CRIT-LINE Clip (CLiC) Blood Chamber is a sterile, single use, disposable, optical cuvette designed for use with the CLiC Monitor's sensor clip during acute and chronic herapy to non-invasively measure hematocrit, percent change in blood volume, and oxygen saturation. The blood chamber is connected between the arterial bloodline and the dialyzer within the extracorporeal circuit during hemodialysis treatment.

The CRIT LINE™ Clip (CLiC) Blood Chamber is a non-invasive, disposable, transparent optical cuvette designed as a connection between the arterial bloodline and the hemodialyzer in the extracorporeal circuit during hemodialysis treatment. The chamber's two (2) polycarbonate viewing lenses serve to secure the CLiC Monitor's sensor clip and provide a uniform cross section, allowing a clear blood passage for the CLiC Monitor to transmit light through the blood. The CLiC Monitor uses the principle of light absorption to measure oxygen saturation (O2 SAT) and hematocrit (HCT) levels in the blood.