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SecureLoc™ Safety Introducer Needles are intended to be used for those patients requiring percutaneous procedures utilizing an introducer needle for guidewire placement for subsequent placement of catheters or other introducer needle required medical procedures. The SecureLoc™ Safety Introducer Needles are intended to be used as integral safety procedure needles for those patients requiring percutaneous procedures utilizing an introducer needle for guidewire placement for subsequent placement of catheters or other introducer needle required medical procedures. The SecureLoc™ Safety Introducer Needle's safety engineered integral safety guard is advanced by the clinician. The safety guard automatically senses the end of the needle and reduces the risk of accidental needlestick injuries by locking a safety guard covering the needle tip. The safety guard can be activated over stylettes, obturators, and guidewires. Will be marketed as bulk non-sterile single use devices to procedural kit manufacturers and also as sterile, non-pyrogenic, single use devices to clinical endusers. May be used in any appropriate patient population. AdvancIntroducer™ Introducer Needles are intended to be used with those patients requiring percutaneous entry procedures utilizing an introducer needle for guidewire placement for subsequent placement of catheters or other introducer needle required medical procedures. Will be marketed as bulk non-sterile single use devices to procedural kit manufacturers and also as sterile, non-pyrogenic, single use devices to clinical endusers. May be used in any appropriate patient population.

The AdvancIntroducer™ needles consist of a stainless steel needle and a colored translucent standard female Luer lock hub locking connector for rapid (flashback) visualization. The hub has a bevel-up orientation indicator. The hub has been designed to provide the end-user excellent ergonomic tactile balance and stability. The AdvancIntroducer™ needles are available in one-wall with or without a Seldinger shield. The stainless steel needles are available with and without an echogenic feature or a specialty coating to enhance available war and with oneedles are available in a range of wall thicknesses, gauges and lengths to match the end-user need. AdvancIntroducer™ needles will be marketed to the clinical end-user as sterile, nonpyrogenic, and single use devices. Additionally, the device will be marketed as the safety procedure needle in procedure trays. In the case of being used in procedural kits, the product will be shipped bulk non-sterile to the kitting manufacturer. The AdvancIntroducer™ will be incorporated into the procedure kit, packaged and sterilized. SecureLoc™ Safety Introducer Needles have all the same components as the AdvancIntroducer™ and in addition, incorporates an intuitive easy to use safety guard which is an integral part of the device. SecureLoc™ Safety Introducer Needles are designed for common Introducer needle lengths and gauges. Obturators and stylettes are appropriately available. Stylette handles have an incorporated key to align to the cutting bevel. The SecureLoc™ Safety Introducer Needle's safety engineered integral safety guard is advanced by the clinician. The safety guard automatically senses the end of the needle and locks a safety guard covering the needle tip. The SecureLoc™ Safety Introducer Needle's easy to use intuitive safety guard reduces the risk of accidental needlestick injuries by shielding the needle tip. A visual, tactile feel, and/or audible confirmation of the locking component over the needle confirms lockout of the safety guard over the needle. The sharps injury prevention guard cannot be deactivated and remains protective through disposal into a sharps container. The safety guard can be activated over stylettes, obturators, and guidewires. SecureLoc™ Safety Introducer Needles will be marketed to the clinical end-user as sterile, non-pyrogenic, single use devices. Additionally, the device will be marketed as the safety procedure needle in procedure trays. In the case of being used in procedural kits, the product will be shipped bulk non-sterile to the kitting manufacturer. The SecureLoc™ Safety Introducer will be incorporated into the procedure kit, which is then packaged and sterilized.

- The LiftLoc™ Safety Infusion Set device is a safety intravascular administration set with a non-coring right angle Huber needle, used to access surgically implanted vascular ports. - The integral LiftLoc™ Safety Infusion Set safety mechanism is manually activated during the removal of the LiftLoc™ Safety Infusion Set needle from a surgically implanted vascular port. The safety mechanism reduces the risk of accidental needlestick injuries by shielding the needle. - The LiftLoc™ Safety Infusion Set is intended for use in the administration of fluids and drugs, or blood sampling through surgically implanted vascular ports. - The LiftLoc™ Safety Infusion Set will be marketed as a sterile, non-pyrogenic, single use device. - The LiftLoc™ Safety Infusion Set may be used in any appropriate patient population.

The LiftLoc™ Safety Infusion Set is a standard non-coring Huber type needle and administration set with an integral safety needlestick prevention feature. The LiftLoc™ Safety Infusion Set 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 LiftLoc™ Safety Infusion Set is supplied sterile and non-pyrogenic, for single use only. Following conventional placement of the LiftLoc™ Safety Infusion Set's Huber needle into the implanted port and completion of either the prescribed infusion of fluids or blood sample withdrawal, the LiftLoc™ Safety Infusion Set may then be removed from the patient. Conventional clinical practice is used to remove the LiftLoc™ Safety Infusion Set from the implanted port. Fingers of the non-dominant hand are placed on top of the LiftLoc™ safety disc to stabilize the port. A one-handed (dominant hand) technique is then used to grasp the integral wings and pull upward to remove the Huber needle from the port. When the clinician's hands are positioned correctly over the LiftLoc™ safety disc and the needle is removed, the integral safety mechanism is activated and locks a safety shield covering the needle. An audible click or visual confirmation confirms the lockout of the safety shield over the needle. The LiftLoc™ Safety Infusion Set, now with a protected needle, is discarded in a sharps container. The product has two configurations: one with an adaptable Y-injection site and one without. A Patient Comfort Pad will also be available as an accessory.

The ExtreSafe™ Phlebotomy device is intended to be used in phlebotomy procedures using vacuum blood collection tubes. A powered needle retraction feature provided a shield for the necure f 11 following use.

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For storage and disposal of used sharps devices

The device is a molded plastic container with various features designed to allow the admission of used sharps while preventing the user from coming in contact with the contents of the container. It has provisions for both temporary and permanent closure of the container. When closed permanently, the container is disposed of in accordance with medical waste procedures. The Safety Cradle sharps container utilizes a unique two part design that provides the following features: 1. Unique automatic closure means for the disposal of sharps utilizing a biased flap referred to as the Safety Cradle, a living hinge and a depressable cover that is linked to the biased flap and living hinge. 2. A secondary temporary closure with temporary lock and a handle for safe transport. In between uses, the biased flap and cover provide two barriers of protection against exposure to sharps within the container. 3. Permanent closure when container is full. 4. Highly absorbent pad with gelling compound for fluid control. 5. Left handed and right handed phlebotomy needle extractors. 6. Multiple uses in applications that include a wall mounted container, table mount use and as a free standing container. 7. Safety Cradle feature provides a unique means for a horizontal drop of a sharp.