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The Nipro SafeTouch LOCKTAIL™ is intended for use as a blood access device for blood purification and for other treatments requiring extracorporeal circuit. The Nipro SafeTouch LOCKTAIL ™ aids in the prevention of accidental needle stick injuries. The compatibility of available configurations is the responsibility of the physician in charge.

The NIPRO SafeTouch LockTail™ Safety Fistula Needle is a sterile, single use, safety AVF needle. It consists of an arterial and venous adapter, flexible tube and needle with an active sharps safety feature (non-implanted blood access device) as described in 21 CFR 876.5540. The NIPRO SafeTouch LockTail "" includes 2 basic types of designs; fixed wing type (stationary) and turnable wing type (rotating). These two designs are offered in 80 configurations with options that include needle gauge (14-18G), needle length (1" and 1 ¼"), type of needle (with or without backeye), clamp color (white, red/blue), and tubing length (150 and 300 mm). The integrated sharps injury prevention feature requires physical action by the clinician to activate and is designed to cover the needle tip after treatment. Correct use of this anti-stick feature will eliminate accidental needlesticks. These devices operate on the principles of a blood access device. They are sterile, single use only, non-toxic and non-pyrogenic.

This product is a safety intravascular administration set and is indicated for the administration of fluids and drugs, or blood sampling through surgically implanted vascular ports. Secondly it incorporates a safety mechanism to help protect against exposure to blood borne pathogens caused by accidental needlestick injuries.

The Nipro SafeTouch Huber Infusion Set is a standard non-coring Huber type needle and administration set with an integrated safety mechanism to prevent in accidental needlesticks. This device is designed for use with a vascular access infusion system and is intended for use as an intravascular administration set to access surgically implanted subcutaneous vascular ports in a standard manner for the purposes of fluid or drug infusion and blood sampling.

The Nipro® Set - Blood Tubing Set with Transducer Protector and Priming Set are disposable bloodlines intended to provide extracorporeal access to the patient's blood during Hemodialysis. The compatibility of available configurations is the responsibility of the physician in charge.

The Nipro® Blood Tubing Set with Transducer Protector and Priming Set includes arterial and venous dialysis blood tubing with transducer protectors and priming set (non-implanted blood access device) as described in 21 CFR 876.5820. The devices are packaged together for convenient use during hemodialysis procedures. There are 13 different configurations of the arterial line and 6 different configurations of the venous line. The various blood set models are being manufactured for application with various models of dialysis machines. 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 and monitor pressure. The devices are packaged sterile and labeled for single use only. There is no ability to clean and reuse these devices. They are restricted for sale by or on the order of a physician.

The NIPRO BioHole™ Needle is intended for use as a blood access device for dialysis procedures using a constant-site cannulation technique of needle insertion with an established, mature constant-site also known as a buttonhole access site.

The NIPRO BioHole™ Needle is a sterile, single-use device that consists of a hollow, winged needle, a flexible tube, mini clamp and locking connector. This device is provided in four design types: fixed wing type A, turnable wing type A, fixed wing type B, turnable wing type B. Needles are available in two lengths, 1" and 1¼", as well as four gauges (14-17), with and without back eye. The flexible tubing comes in lengths of 150mm and 300mm. The NIPRO BioHole™ Needle is packaged individually in a plastic pouch with paper backing, which contains labeling that adequately defines indications for use and warnings. These devices operate on the principles of a blood access device. They are sterile, single use only, non-toxic and non-pyrogenic.

The NIPRO® Safetouch II Gamma is intended for use as a blood access device for blood purification and for other treatments requiring an extracorporeal circuit of larger volumes of blood. Secondly, it is designed with an active sharps safety feature requiring physical action by the clinician to aid in the prevention of accidental needlesticks. The compatibility of available configurations is the responsibility of the physician in charge.

The NIPRO® SafeTouch II Gamma is a sterile, single use, safety AVF needle. It includes 2 basic types of designs; fixed wing type (stationary) and turnable wing type (rotating). These two designs are offered in 64 configurations with options that include needle gauge, needle length, type of needle (with or without backeye), and tubing length. The NIPRO® SafeTouch II Gamma includes an arterial and venous fistula adapter consisting of flexible tube and needle with an active sharps safety feature (nonimplanted blood access device) as described in 21 CFR 876.5540. The safety feature is easily operated through the release of a latch mechanism whereby the user slides a winged cover over the needle, as it is removed from the patient. Once the needle is covered, the safety cover locks into place. The only difference being the material used for the protector which has changed from a frosted to a transparent component, making it easier to confirm blood flash black. These devices operate on the principles of a blood access device. They are sterile, single use only, non-toxic and non-pyrogenic.

The Nipro Hypodermic Needle is intended for use to inject fluids into or withdraw fluids from parts of the body below the surface of the skin.

The subject devices can be classified as single use hypodermic needles as described in 21 CFR 880.5570. Needle sizes include 16-30 Gauge, lengths of ½ to 1 ½ inches, and regular or short bevels.

The Disposable Hypodermic Syringes with or without Needle are intended for use to inject fluids into or withdraw fluids from the body.

The subject devices can be classified as piston syringes as described in 21 CFR 880.5860. Among the syringe types described are: luer lock, slip-tip, eccentric, and catheter tip. Syringes will be packaged with and without needles. Various sizes are described including: 1, 3, 5, 10, 20, 30, and 60 milliliters.

The Nipro Disposable Stopcocks are intended for use to change the direction of flow of fluids through a tubing set.

The subject devices can be classified as stopcocks as described in 21 CFR 880.5440. Among the types described here are: click - stop; 3W-R; 3W-L; and, NCN. Both slip tip and luer lock are included.

The Nipro® SafeTouch Safety Fistula Needle is intended for use as a blood access device for blood purification and for other treatments requiring an extracorporeal circuit or larger volumes of blood. Secondly, it is designed with an active sharp safety feature requiring physical action by the clinician to aid in the prevention of accidental needle stick injuries.

The Nipro® SafeTouch Safety Fistula Needle includes arterial and venous fistula adapter consisting of flexible tube and needle with an active sharps safety feature (non-implanted blood access device) as described in 21 CFR 876.5540. The fistula needle included in this 510(k) is modified to include a change in material of the Safety AVF hub from ABS to PMMA compounds consisting of Methyl Methacrylate Polymer and Butadiene Polymer and a change in the shape of the Safety AVF stopper to enhance the activation of the safety mechanism. The sharps injury prevention system is connected between winged needle and polyvinyl chloride tubing and consists of three parts, the Safety Hub, Safety Stopper and Safety Protector. The needle is attached to the Safety Hub and is connected to the Safety Stopper. The Safety Protector then covers the Safety Hub. The safety feature is easily operated through the release of a latch mechanism whereby the user slides a winged cover over the needle, as it is removed from the patient. Once the needle is covered, the safety cover latches into place. The Nipro® SafeTouch Safety Fistula Needle includes 2 basic types of design with clamps which remain the same: fixed wing type (stationary) and turnable wing type (rotating) which is offered in 96 configurations with options within it to include needle gauge, needle length, type of needle, and tubing length availability. The devices are packaged sterile and are labeled for single use only.

The Nipro Disposable Syringes are intended for use to inject fluids into or withdraw fluids from the body.

The subject devices can be classified as piston syringes as described in 21 CFR 880.5860. Among the syringe types described here are: flat-head; circular irrigation syringes; and, screw nozzle syringes. Various sizes are described including: 1, 2, 2.5, 3, 5, 10, 20, 30, 50, and 100 milliliters.