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The Dimesol Disposable A.V. Fistula Needle Sets are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment. This device is for inhospital or hemodialysis center use only. The Dimesol Disposable A.V. Fistula Needle Sets (Safety Needle Series) are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment. Protective Shield aids in the prevention of accidental needlesticks. This device is for inhospital or hemodialysis center use only. The Dimesol Disposable A.V. Fistula Needle Sets are intended for use as a nonimplantable (i.e., less than 30 days use) vascular/blood access device for temporary cannulation in procedures requiring an extracorporeal circuit, such as hemodialysis. The Dimesol Disposable A.V. Fistula Needle Sets are intended for use as a nonimplantable (less than 30 days use) vascular access device for temporary cannulation in procedures requiring an extracorporeal circuit, such as hemodialysis.

The Dimesol Disposable A.V. Fistula Needle Sets are intended for use as a nonimplantable (i.e., less than 30 days use) vascular/blood access device for temporary cannulation in procedures requiring an extracorporeal circuit, such as hemodialysis. The cannula (needle) of the device is used to puncture the appropriate area of a patient and the opposite end of the device is attached to a blood tubing set. Typically, two needle sets are used for each treatment. The first set is used to access the patient's artery to transfer blood to the dialyzer and the second set is used to access the patient's vein to transfer filtered blood back to the patient's body. The AV fistula needle sets are available in two main variants: (i) needle sets that do not include a safety feature; and (ii) needle sets that do include a safety feature. The safety feature is a protective shield that covers the cannula after use and requires physical action by the clinician to activate. Both variants are sterile and intended for single use only. Both variants are provided in a fixed-wing design (stationary) and a rotatable wing design (rotatable). The major components of these AV fistula needle sets are manufactured from medical-grade polyvinyl chloride, polypropylene, fire-retardant polyethylene, and other medical-grade macromolecule materials and innocuous stainless steel. These AV fistula needle sets are latex-free and can be inserted into a patient's vein and then connected to a hemodialysis bloodline tubing set. The tubing is soft, transparent, smooth and non-kink. The wings of the needle set are suitably rigid, and the on/off clamps are simple and convenient with regard to use. The wing for 15G is Blue, 16G is Green, and 17G is Red. The tip of the cannula is sharpened to reduce the pain for the patient. The backeye is slender and close to the cannula tip and is slipresistant for smooth puncturing. The Dimesol Disposable A.V. Fistula Needle Sets without safety shield includes the following structural components: (1) a protective cap for the cannula; (2) a cannula (arterial or venous); (3) a hub; (4) a color-coded fixed or rotatable gripping wing; (5) flexible tubing; (6) a small on/off hemostatic clamp; (7) a connective female luer lock; and (8) a cap for the female luer lock. These AV fistula needle sets are sterilized using gamma radiation. The patient and/or blood contacting components are the cannula, the tubing segment, and the luer lock. The Dimesol Disposable A.V. Fistula Needle Sets with safety shield includes the following structural components: (1) a protective polypropylene cap for the cannula; (2) a cannula (arterial or venous); (3) a hub; (4) a color-coded fixed or rotatable gripping wing; (5) a safety shield for encapsulating the cannula after use; (6) flexible tubing; (7) a small on/off hemostatic clamp; (8) a connective female luer lock; and (9) a cap for the female leur lock. These AV fistula needle sets are sterilized using gamma radiation. The patient and/or blood contacting components are the cannula, the hub, the tubing segment, and the luer lock. The protective shield component is generally tubular in shape and includes a locking mechanism that is adapted to secure the hub inside the protective shield when the hub is in its retracted position. The locking mechanism prevents the needle from inadvertently protruding out of the protective shield, thereby ensuring safe disposal of the cannula after use. The oppositely placed axial slots on the protective shield are adapted to receive the wings when the hub moves into the protective shield, thereby ensuring a correct rotational position of the protective shield relative to the hub. The axial length of the slots is long enough to receive both the hub and the cannula, particular the sharp tip of the cannula, thereby preventing accidental exposure to the tip of the needle. The locking mechanism includes two locking aspects. With regard to the first locking aspect, the tubular wall is spread apart when the hub moves into the protective shield. The lower portion of the tubular wall includes a curve that facilitates the insertion of the upper tubular wall includes a locking hoot that maintains the wings in a downward position when the hub moves into the slot. This aspect facilitates the continuous transition of the hub and wings from the minimum width regions of the slots toward the enlarged regions of the slots. With regard to the second locking aspect, two asymmetric locking hooks extend from the tubular walls. These hooks maintain the hub and winds in the enlarged slot. The cannula and hub are thus fully received and locked inside the protective shield and the device may be disposed of in a safe manner. An audible click indicates to the user that the device is in its final locked position.

The Dimesol Tubing Sets for Hemodialysis are single-use sterile medical devices intended to connect the patient to the hemodialyzer and the hemodialysis delivery system in hemodialysis treatment. The compatibility of available configurations is the responsibility of the physician / clinician in charge.

The Dimesol blood tubing sets for hemodialysis are single use arterial and venous blood line (tubing) sets for use with polyethersulfone hollow-fiber hemodialyzers or other dialyzers that are indicated for hemodialysis treatment of acute and chronic renal failure. These tubing sets are intended for use as the extracorporeal blood circuit during hemodialysis and to connect a dialysis patient to a hemodialyzer. These tubing sets are intended for single use only. The major device components of these tubing sets are manufactured from medical-grade polyvinyl chloride (PVC), polypropylene (PP), polycarbonate (PC), acrylonitrile butadiene styrene (ABS), and fire-retardant polyethylene (PE).