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SwabCap® is intended for use on swab-able luer access valves as a cover to protect the luer access valves from potential contamination. The SwabCap® acts as a physical barrier to contamination between line accesses and also serves as a disinfecting cleaner for use prior to line access. SwabCap® will disinfect the valve five (5) minutes after application and maintains a disinfected valve surface for up to seven (7) days if not removed.

SwabCap is a plastic threaded cap that houses a small sponge saturated with 70% isopropyl alcohol. The device is designed to securely fit on swab-able luer access valves to disinfect the valve surface and maintain antiseptic conditions between line accesses. SwabCap" is a sterile, single-use device, provided as a stand-alone product.

The flush syringe is intended for flushing of IV catheters and IV tubing. SwabCap® is intended for use on a swab-able luer access valve as a disinfecting cleaner prior to line access and to act as a physical barrier to contamination between the line accesses. SwabCap® will disinfect the valve five (5) minutes after application and act as a physical barrier to contamination for up to ninety-six (96) hours under normal conditions if not removed. The SwabFlush™ product is provided as: 1. 10 ml fill in 10 ml saline flush syringe with integrated SwabCap®. 2. 5 ml fill in 10 ml saline flush syringe with integrated SwabCap®. 3. 3 ml fill in 10 ml saline flush syringe with integrated SwabCap®.

SwabFlush" is a saline intravenous flush syringe that is combined with an integrated SwabCap®. Each SwabFlush" syringe contains a sterile, non-pyrogenic isotonic solution of 0.9% Sodium Chloride Injection USP, 9 mg NaCl per ml, with an osmolarity of 0.3 l mOsm/mL, pH 4.5 - 7.0. A SwabCap® is a luer access valve cap that contains 70% isopropyl alcohol as a disinfectant. A SwabCap® is designed to securely fit on swab-able luer access valves. The product is intended for single-use and is provided sterile. The SwabFlush" provides the healthcare professional with immediate access to the SwabCap luer access valve disinfectant cap after an IV flush.

SwabCap ™ is intended for use on swab-able luer access valves as a disinfecting cleaner prior to line access and to act as a physical barrier to contamination between line accesses. SwabCap ™ will disinfect the valve five (5) minutes after application and act as a physical barrier to contamination for up to ninety-six (96) hours under normal conditions if not removed.

The SwabCap™ is designed to securely fit on swab-able luer access valves. The cap contains 70% isopropyl alcohol. The product is intended for single-use and is provided sterile, latex free, preservative free and DEHP free.

Excelsior Sterile Field Saline Flush Syringe(s) are intended for use in flushing IV catheters and IV tubing.

The Excelsior Medical Saline pre-filled Syringe(s) in Sterile Field Packaging will contain 10ml of 0.9% sodium chloride solution, USP in a 10 ml syringe. This device will be marketed as one or two syringes packaged in a sterile pouch. Each syringe will contain a white tip cap and associated label with a clear backeround. In addition, the syringe label will contain a lot number, expiration date and graduation marking. Each filled and labeled syringe will be packaged in a pouch which is a two part envelope that contains printed information on one side and is clear on the other side.

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.

Excelsior Sterile Field Saline Flush Syringes and Heparin Lock Flush Syringes are intended for flushing IV catheters and IV tubing.

The modification which is the subject of this Special 510(k) is substitution of the current dust cover packaging with Sterile Field packaging. All other aspects of the product design remain unchanged.

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