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The DORA Disposable A.V. Fistula Needle Sets (Safety Needle Series) are sterile medical devices intended to be used as vein puncture for hemodialysis treatment. Protective Shield is used for protecting from needlestick imiury. The DORA Disposable A.V. Fistula Needle Sets are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment. The DORA Disposable A.V. Fistula Needle Series) are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment. Scab Remover is used for remove the scab at puncture position.

The proposed device, DORA Disposable A.V. Fistula Needle Sets, is a non-implantable blood access device, which mainly consists of flexible tube and sharp needle. It is available in three types, 1) Needle sets with safety feature, 2) Needle sets without safety feature and 3 > Dull Needle sets. Both the three types of proposed device are provided sterile and are for single use only. The three types of proposed devices are offered in difference configurations with options that include needle gauge, needle length, wing types (fixed wing or rotatable wing). The proposed device and its package are designed to be provided in Ebeam sterilization. The package could maintain the sterility of the device for three years. The Protective Shield for injury prevention requires physical action by the clinician to activate and is designed to cover the cannula after treatment. Correct use of this safety feature will eliminate accidental needlestick injuries.

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 DORA 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. The DORA Disposable A.V. Fistula Needle Sets are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment.

The proposed device, DORA Disposable A.V. Fistula Needle Sets, is a non-implantable blood access device, which mainly consists of an adaptor, flexible tube and sharp needle. It is available in two types, 1) Needle sets with safety feature and 2) Needle sets without safety feature. Both the two types of proposed device are provided sterile and are for single use only. The two types of proposed devices are offered in difference configurations with options that include needle gauge, needle length, wing types (fixed wing or rotatable wing). The proposed device and its package are designed to be provided in Gamma sterilization. The package could maintain the sterility of the device for three years. The Protective Shield for injury prevention requires physical action by the clinician to activate and is designed to cover the cannula after treatment. Correct use of this safety feature will eliminate accidental needlestick injuries. The proposed device is used in conjunction with following hemodialysis blood tubing sets during clincial use.

JMS Harmony® A.V.Fistula Needle Set is intended for temporary cannulation (non-implantable, less than 30 days) to vascular access for extracorporeal blood treatment and for the removal of scabs that have developed over the constant site prior to cannulation. The device is intended for single use only and is used on 'developed constant site' access sites. This device is for use on developed 'constant site' access sites

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The Angel Tip Safety Intravascular Needle Set is indicated to access the peripheral vascular system for hemodialysis. Additionally, after withdrawal of the needle from the patient's vein, the needle can be manually retracted within a safety enclosure to minimize the risk of an accidental needle stick.

The safety needle portion of the Angel Tip Safety Intravascular Needle Set will be available in diameters ranging from 14 to 18 Ga and lengths of 1.0 to 1.5 inches. The Angel Tip Safety Intravascular Needle Sets are sterile, single use devices designed to access the peripheral vascular system for hemodialysis. Additionally, after withdrawal of the needle from the patient's vein, the needle can be manually retracted within a safety enclosure to minimize the risk of an accidental needle stick. The Angel Tip Safety Intravascular Needle Set consists of a needle attached to a winged hub, microbore or macrobore tubing, adapter and adapter cap and a safety enclosure that attaches to the winged hub. As the needle is removed from the patient's vessel, the user's finger actively slides the safety enclosure until it latches onto the needle using a one- or two-handed technique. The user will know the needle is engaged based on the tethers being fully extended and hearing an audible click. The safety enclosure is designed to allow the user's fingers to remain behind the needle point so that the risk of needle stick injury is minimized. The enclosure is clear so the user has a visual means of knowing the needle is captured.

Use for temporary cannulation non-implantable, less than 30 days) to vascular access for extra corporeal blood treatment. The device is intended for single use only and has an anti-stick feature integrated as part of the Needle Set which aids in prevention of needle-stick injuries

SysLoc® MINI (V4) is intended as non-implanted blood access device, which consists of flexible tube and needle with integrated sharp safety features as described in 21 CFR 876.5540. SysLoc® MINI (V4) comes with a rotational feature and the needle is retracted with the wing sheath after deliberate release of secured external lock, and final locking is assured by an audible 'click' sound when the hub/tube is pulled rearwards.

The Medisystems Dual Lumen Needle is indicated for use as a vascular access device for dialysis procedures. The Medisystems Dual Lumen Buttonhole Needle is indicated fo use as a vascular access device for dialysis procedures using a constant-site or "buttonhole" method of needle insertion.

The proposed devices are to be used as a vascular access device for dialysis procedures using either a standard needle insertion technique (for Dual Lumen Needle) or a constant-site or "buttonhole" method of insertion (for Dual Lumen Buttonhole Needle).

The A.V. Fistula Needle Set is intended for temporary cannulation (non-implantable, less than 30 days) to vascular access for extracorporeal blood treatment. The device is intended for single use only.

A.V. Fistula Needle Set is a single-use fistula needle which is inserted for temporary cannulation (non-implantable, less than 30 days) to vascular access for extracorporeal blood treatment. The device consists of a needle that is attached to wings, a flexible tube and a luer lock connector.

Use for providing access to a donor's blood for apheresis. This device is intended to single use only and is for temporary catheterization less than 30 days. The safety feature (foldable wing and WingEater) aids in prevention of needlestick injuries when removing and discarding needle after blood collection.

JMS Apheresis Needle Set "WingEater" V2 is a device whereby an antineedlestick feature (WingEater guard) is assembled with predicate device under 510(k), K00845. Needlestick injury can be prevented by pulling the PVC tube to retract the needle and wing into WingEater guard when removing needle so as to encapsulate the whole needle within the WingEater guard. Modifications to JMS Apheresis Needle Set "WingEater®" V2 in this special 510(k) are: - Additional new polypropylene (PP) materials used for WingEater a) guard, needle cover, luer lock cover and clamp (non fluid pathway) There are other non-significant changes which were made to 510(k) -K010410 in the past. These changes are listed under Attachment 004 List of Past Changes of this special 510(k). Evaluation of the new packaging configuration was performed accordingly to stimulated conditions experienced during transportation. New design and material used for the WingEater guard was evaluated accordingly with folded wing in order to realize the actual device usage. Reviews of the modifications were documented within this special 510(k) submission.

Use for temporary cannulation for vascular access for extracorporeal blood treatment. The device is intended to single use only and is for temporary catheterization less than 30 days. The safety feature (foldable wing and WingEater guard) aids in prevention of needlestick injuries when removing and discarding needle after dialysis session.

JMS A.V. Fistula Needle Set "WingEater®V2 is a device whereby an antineedlestick feature (WingEater guard) is assembled with predicate device under 510(k), K000845. Needlestick injury can be prevented when removing needle so as to encapsulate the whole needle within the WingEater guard. Modifications to JMS A.V. Fistula Needle Set "WingEater®V2 in this special 510(k) are: a) Additional new polypropylene (PP) materials used for WingEater guard, needle cover, luer lock cover and clamp (non fluid pathway)