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The Heparin Lock Flush Solution, USP, BD PosiFlush™ Heparin Lock Flush Syringes are intended for maintenance of patency of vascular access devices only.

Heparin Lock Flush Solution, USP, BD PosiFlush™ Heparin Lock Flush Syringe (also referred to as BD PosiFlush" Heparin Lock Flush Syringe) is provided in either 10 or 100 Units/mL concentrations in 0.9% Sodium Chloride Injection, USP packaged in a plastic, disposable, single use syringe. The syringe is a three-piece, single use syringe with a 6% (luer) connector prefilled with Heparin Lock Flush Solution, and sealed with a tip cap. The BD PosiFlush"" Heparin Lock Flush Syringe is provided in a 3mL or 5mL size configuration. The BD PosiFlush™ Heparin Lock Flush Syringe is provided with a sterile fluid path, sterilized via moist heat. The solution is delivered through the vascular access device to maintain catheter patency and is not to be used for anticoagulation therapy. The change described in this submission is to qualify a new stopper material used in the BD PosiFlush " Heparin Lock Flush Syringe.

Flushing of IV catheters and IV tubing only. Solution is intended for maintenance of patency of intravenous injection devices. Prior to and after administration of intermittent medication, entirely flush the intravenous injection device (catheter and or tubing) with Heparin Lock Solution, USP. Use in accordance with any warnings or precautions appropriate to medication being administered. This device is not to be used for anticoagulant therapy.

Excelsior Medical's Heparin Lock Flush, USP devices are provided as terminally sterilized, single-use, pre-filled, pre-packaged products. The products contain a solution of heparin sodium, USP and 0.9% sodium chloride, USP. The solution is delivered through the luer lock of a venous access device to maintain catheter patency (lock catheters) between treatments. Typically, the venous access device is flushed with normal saline before and after the administration of intermittent medication therapy, blood sampling, total parenteral nutrition, or hemodialysis.

Heparin Lock Flush Solution, USP product code 505701 (10 USP units/mL) and product code 504901 (100 USP Units/mL), is intended to maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.

The Heparin Lock Flush Solution, USP product code 505701 comes in concentration of 10 USP Units/mL, and in strengths of 10 USP units. The Heparin Lock Flush Solution, USP product code 504901 comes in concentration of 100 USP Units/mL, and in strength of 100 USP units. These two product codes are packaged in 3 cc plastic vials.

FOR USE TO MAINTAIN THE PATENCY OF IN-DWELLING INTRAVENOUS VASCULAR ACCESS DEVICES (IVAD)

The Heparin I. V. Flush Syringe (the DEVICE) is a single dose, disposable, sterile, plastic prefilled syringe. The DEVICE consists of a hypodermic syringe barrel, stopper plunger, plunger rod, luer lock (LL) tip cap and Heparin Lock Flush Solution, USP (1 Unit/mL or 10 Units/mL or 100 Units/mL in 0.9% Sodium Chloride), which meets the requirements set forth in the current USP Heparin Lock Flush Solution monograph. Two different sizes (6 mL, 12 mL) of hypodermic syringes will be utilized in packaging. The hypodermic syringe is transparent. The barrel of the reservoir for the product and will be overfilled during manufacturing process. The plunger and plunger rod are the only two moving parts of the device. The flush solution is delivered by pressing down on the plunger rod, resulting in the expulsion of the fluid from the luer tip. The DEVICE will be filled using fully automated syringe filling machine utilizing non - sterile components. The components of the DEVICE (hypodermic syringe, tip cap and (Heparin Lock Flush Solution, USP) will be sterilized using steam in a terminal sterilizer after the syringe barrel is filled with Heparin Lock Flush Solution and sealed with Tip Cap and Plunger Stopper.

The Heparin Lock Flush Solution, USP, BD PosiFlush™ Heparin Lock Flush Syringes are intended for use in maintaining the patency of vascular access devices (VAD's) 10 usp units/mL and 100 usp units/mL in 3ml fill in 3ml syringe with 10ml diameter and 5ml fill in 5ml syringe with 10ml diameter

The Modified Device, the subject of this 510(k), the Heparin Lock Flush Solution, USP -BD PosiFlush Heparin Lock Flush Syringe uses a single use disposable Hypodermic syringe, identical to the Predicate Device (K003553), filled with USP Heparin Lock Flush Solution. The Modified Device has a sterile fluid path with an SAL of 10°. The Modified Device, the subject of this 510(k), the Heparin Lock Flush Solution, USP -BD PosiFlush Heparin Lock Flush Syringe has been modified to achieve terminal sterilization (SAL of 1066) via steam autoclave. The Modified Device is manufactured of similiar materials and has the same intended use as the Predicate Devices.

Excelsior Medical Heparin Lock Flush Syringes (1Unit/ml and 2 Units/ml) are indicated for use in maintaining patnecy of vascular access devices designed for intermittent or infusion therapy. Prior to and after administration of intermittent medication, entirely flush the vascular access device with Heparin Lock Flush Solution, USP. Use in accordance with any warnings or precautions appropriate to medication being administered. This device is not to be used for anticoagulant therapy

Excelsior Medical Heparin Lock Flush Syringes are polypropylene latex-free syringes which contains a labeled volume of a sterile, non-pyrogenic solution of Heparin Lock Flush Solution, USP derived from porcine intestinal mucosa in 0.9 sodium chloride USP with a pH range of 5.0 - 7.5.

Flushing of IV catheters and IV tubing only. Prior to and after administration of intermittent medication, entirely flush the catheter and or tubing with Heparin Lock Flush Solution, either USP 10 Units/mL or USP 100 Units/mL. Use in accordance with any warning or precautions appropriate to medication being administered. This device is not to be used for anticoagulant therapy.

Syrex Pre-Filled Syringe, Heparin Lock Flush Solution, USP 10 and 100 Units/ml