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The DBB-06 Hemodialysis Delivery System 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. The DBB-06 Hemodialysis Delivery System is not indicated for pediatric patients. It is not for home use.

The DBB-06 HEMODIALYSIS DELIVERY SYSTEM is composed of a hydraulic unit for the delivery of dialysate and extracorporeal blood circuitry. The permeate is heated and deaerated in the hydraulic section, which is then mixed with concentrate and fed into the dialyzer through the dialysate fluid feeder. The closed balancing system assures the amount of dialysate infused corresponds to the amount of dialysate extracted. The interior pressure of the dialyzer is controlled automatically by adjustment of the ultra filtration amount and UF rate by the dialyzer. Heparinization of the external circulating blood is accomplished with the heparin pump either by continuous or bolus injection before it is passed on to the dialyzer. The DBB-06 HEMODIALYSIS DELIVERY SYSTEM uses both acetate dialysis and bicarbonate dialysis. Utilizing the various functions of the device, the conductivity and UF profile can be programmed. In addition, the device incorporates all functions necessary for double-needle dialysis as well as single-needle dialysis procedures. The hydraulic unit is cleaned and disinfected using selectable cleaning programs and is equipped with protective systems for patient safety and proper operation. A Blood Volume Monitor (BVM) is an optional accessory available for the DBB-06 HEMODIALYSIS DELIVERY SYSTEM, and was not available with the predicate device, the DBB-05 Hemodialysis Delivery System. The BVM monitors blood volume to assist in the prevention of excessive removal of fluid.

The NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS are disposable bloodlines intended to provide extracorporeal access to a patient's blood during hemodialysis. The compatibility of available configurations is the responsibility of the physician or other licensed practitioner.

The NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS includes arterial and venous dialysis blood tubing (non-implanted blood access device) as described in 21 CFR 876.5820. The devices are packaged together for convenient use during for hemodialysis procedures. Three models of the NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS (AV06A-P, AV06B-P, AV06C-P) are being manufactured for use with the Nikkiso DBB-05 Hemodialysis Delivery System (K061519). The components of the NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS include pump tubing, air trap chambers, transducer filters, pressure monitoring lines, infusion lines for saline, access ports and tubing clamps which are all used to pump blood, retain and capture blood debris, infuse medications or fluids, sample blood, monitor pressure, and make connections to other devices. Major materials used for the various components are Polyvinyl chloride (PVC), polycarbonate (PC), polypropylene (PP). Materials in direct contact with blood are Polycarbonate (PC), Polyvinyl chloride (PVC), Silicone, Polypropylene (PP) and Polytetrafluoroethylene (PTFE). The NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS are restricted for sale by or on the orders of a physician. The NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS are packaged sterile and labeled for single use only and non-pyrogenic.

The DBB-05 Hemodialysis Delivery System is indicated for hemodialysis prescribed by physicians for adult and pediatric patients with acute or chronic renal failure. The DBB-05 is intended for hemodialysis performed in hospitals and dialysis clinics by a qualified operator.

The DBB-05 Hemodialysis Delivery System is composed of a hydraulic unit for the delivery of dialysate and extracorporeal blood circuitry. The permeate is heated and deaerated in the hydraulic section, which is then mixed with concentrate and fed into the dialyser through the dialysate fluid feeder. The closed balancing system assures the amount of dialysate infused corresponds to the amount of dialysate extracted. The interior pressure of the dialyser is controlled automatically by adjustment of the Ultra Filtration (UF) amount and UF rate by the dialyser. Heparinization of the external circulating blood is performed with the heparin pump either by continuous or one-shot injection before it is passed on to the dialyser. The DBB-05 Hemodialysis Delivery System uses both acetate dialysis and bicarbonate dialysis. Using the various functions of the device, the conductivity and UF profile can be programmed. In addition, DBB-05 Hemodialysis Delivery System incorporates all functions necessary for double-needle dialysis as well as single-needle dialysis treatment. The hydraulic unit is cleaned and disinfected using selectable cleaning programs and is equipped with the necessary protective systems for patient safety and correct operation.