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

The DEVICE, the subject of this 510 (k), MEDEFLUSH™ Normal Saline I. V. Flush Syringe - Sterile Field Ready (0.9% Sodium Chloride Flush Syringe, USP) will be sealed with tip cap, filled with 0.9% Sodium Chloride solution, sealed with plunger stopper, inspected, plunger rod inserted, labeled and then pouched in steam sterilizable paper pouch prior to terminally sterilization as compared to its predicate device which is sealed with tip cap, filled with 0.9% Sodium Chloride solution, sealed with plunger stopper, steam sterilized and then inspected, plunger rod inserted and labeled prior to packaging. The DEVICE will be marketed in various sizes and fill volumes similar to its predicate device.

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.

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

The DEVICE, the subject of this 510(k), Normal Saline I. V. Flush Syringes (0.9% Sodium Chloride Injection, USP) will be terminally sterilized as compared to its predicate device which was aseptically filled. The DEVICE will be marketed in various sizes and fill volumes similar to its predicate device.

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

The Heparin Flush Syringe (the DEVICE) is a single dose, disposable, sterile, plastic pre-filled syringe. The DEVICE consists of a hypodermic syringe with a hypodermic barrel, stopper plunger, plunger rod, tip cap and Heparin Lock Flush Solution USP. Heparin I. V. Flush Syringe is manufactured in three different concentrations - 1 Unit/mL; 10 Units/mL and 100 Units/mL. Two different sizes (6 mL, 12 mL) of hypodermic syringes will be utilized in manufacturing. The DEVICE will be marketed in the following dosage forms: 1 mL fill in 6 mL Syringe LL 2 mL fill in 6 mL Syringe LL 2.5 mL fill in 6 mL Syringe LL 3 mL fill in 6 mL Syringe LL 3 mL fill in 12 mL Syringe LL 5 mL fill in 6 mL Syringe LL 5 mL fill in 12 mL Syringe LL 10 mL fill in 12 mL Syringe LL The barrel of the syringe is the reservoir for the product. It shall be overfilled during repackaging as per Pharmacopoeial Forum, Volume 26, Number 2: page 471. Plunger and plunger rod are the two moving parts of the DEVICE. The 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 aseptic technique utilizing pre-sterilized components in a Class 100 environment. The sterile components of the DEVICE (hypodermic syringe, tip cap, Heparin Sodium Injection and 0.9% Sodium Chloride Injection, USP) will be purchased from qualified vendors. The DEVICE is used to maintain patency of in-dwelling intravenous access devices (IVAD). The solution is delivered by pressing down on the plunger rod. resulting in the expulsion of the fluid from the luer tip.

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

The Normal Saline Flush Syringe (the DEVICE) is a single dose, disposable, sterile, plastic pre-filled syringe. The DEVICE consists of a hypodermic syringe with a hypodermic barrel, stopper plunger, plunger rod, tip cap and 0.9% Sodium Chloride Iniection, USP. Two different sizes (6 mL, 12 mL) of hypodermic syringes will be utilized in manufacturing. The DEVICE will be marketed in the following dosage forms: 1 mL fill in 6 mL Syringe LL 2 mL fill in 6 mL Syringe LL 2.5 mL fill in 6 mL Syringe LL 3 mL fill in 6 mL Syringe LL 3 mL fill in 12 mL Syringe LL 5 mL fill in 6 mL Syringe LL 5 mL fill in 12 mL Syringe LL 10 mL fill in 12 mL Syringe LL The barrel of the syringe is the reservoir for the product. It shall be overfilled during repackaging as per Pharmacopoeial Forum, Volume 26, Number 2: page 471. Plunger and plunger rod are the two moving parts of the DEVICE. The 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 aseptic technique utilizing pre-sterilized components in a Class 100 environment. The sterile components of the DEVICE (hypodermic syringe, tip cap and 0.9% Sodium Chloride Injection, USP) will be purchased from qualified vendors. The DEVICE is used to maintain patency of in-dwelling intravenous access devices (IVAD). The solution is delivered by pressing down on the plunger rod, resulting in the expulsion of the fluid from the luer tip.

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

Sterile Heparin I. V. Flush Syringe

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

Normal Saline I. V. Flush Syringe