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The AMSafe® NeuFloTM Needleless Connector are intended to use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

AMSafe® NeuFlo™ Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set.

The AMSafe® Pre-Filled Normal Saline Flush Syringe, is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacturer for the appropriate device.

AMSafe® Pre-Filled Normal Saline Flush Syringe is a polypropylene plastic syringe filled with 0.9% sodium chloride for injection, USP, and capped with a polypropylene syringe tip cap.

The AMSafe® 0.9% Sodium Chloride Pre-Filled Normal Saline Flush Syringe, is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacturer for the appropriate device.

AMSafe® Pre-Filled Normal Saline Flush Syringe is a polypropylene plastic syringe filled with 0.9% sodium chloride for injection, USP, and capped with a polypropylene cap. The device will be terminally sterilized by gamma radiation sterilization. The device will be marketed as a 12mL syringe with a 3mL, 5mL, or 10mL fill volume, and a 20mL syringe with 20mL fill volume. The products are in two different packages, one is poly blister package and the entire packaged device are gamma radiation sterilized for sterile delivery to a sterile field; another is PP wrapper as a dust cover for non-sterile field. The solution is sterile normal saline for injection and meets the requirements of USP<40>.

The AMSafe® Sure-Lok™ Needle-Free Connector is an accessory to an Intra-vascular Administration Set used as a secondary sterile injection site for delivery of fluids to a patient's vascular system through a cannula inserted into a vein.

The AMSafe® Sure-Lok™ Needle-Free Connector is a Needle-Free connector intended for single patient use, for direct injection, intermittent infusion, continuous infusion or aspiration of drugs, blood and fluids used as an accessory to an Intravascular administration set without the use of a needle, thus eliminating the risk of needlestick injuries. The AMSafe® Sure-Lok™ Needle-Free Connector is a closed, Luer activated device that allows for negative fluid displacement. The AMSafe® Sure-Lok™ Needle-Free Connector individually packaged is supplied as a sterile, non-pyrogenic, single use, disposable device.

Pre-filled Syringe for Balloon Inflation with Sterile Water is intended to be used in inflating foley catheter balloon.

The AMSure® Pre-filled Syringe for Balloon Inflation with Sterile Water is a 3cc, 5cc, 10cc and 30cc syringe pre-filled with USP purified water and gamma irradiated. The syringe is produced using polypropylene for the device barrel and plunger and pharmaceutical grade latex free rubber for both the plunger gasket and syringe tip cover. The shelf life of AMSure® Pre-filled Syringe for Balloon Inflation with Sterile Water is 3 years.

The AMSure® Enteral Feeding Syringe with ENFit Tip is indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral syringes are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to clinicians in adults only.

The AMSure® Enteral Feeding Syringes with ENFit Tip are standard piston style syringes consisting of a syringe barrel with ENFit syringe nozzle, syringe plunger, syringe stopper and protective cap. The devices are made with polypropylene and polyisoprene rubber. The plunger can be linearly pulled and pushed along the inside wall of the barrel, allowing the syringe to take in and expel fluid through the nozzle at the front end of the barrel. The integral syringe nozzle has a female ENFit connector designed to be compatible only with enteral access devices or accessories having ENFit compliant or compatible male connectors to form a dedicated system that prevents wrong-route administration of fluids. The Enteral Feeding Syringes with ENFit Tip have a capacity of 60mL for single-use. The devices are provided either sterilized by EtO or non-sterile.

The AMSINO® I.V. ADMINISTRATION EXTENSION SET is a device intended to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein.

The AMSINO® I.V. ADMINISTRATION EXTENSION SET is a single use, latex-free, Non-DEHP, gravity feed, sterile device sterilized with Ethylene Oxide Gas. It is used to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein. The EXTENSION SET will provide a tubing extension to increase the length of an I.V. set or a syringe. The Extension Set consists of various parts such as: drip chamber, luer adapter/connectors, clamp, tubing, flow controller, Y-site, latex-free injection port, needleless injection port, stopcock, flashbulb, filter and manifold.

AMSURE® 3-Way Hydrophilic Latex Foley Catheter is intended to be used for bladder/urinary tract drainage and bladder/urinary tract irrigation for urological use only.

The AMSURE® 3-WAY Hydrophilic Latex Foley Catheter is a retention type urological catheter made of silicone coated natural latex material modified with the addition of a lubricious/hydrophilic coating to facilitate insertion of the catheter. This device is a Latex tube with three lumens: one lumen for urinary drainage which is to be connected to a urine collecting container; one lumen with two-way valve for inflation/deflation of the foley balloon and one lumen for irrigation of the bladder/urinary tract. The 3-Way Hydrophilic Latex Foley Catheter is coated with a lubricious hydrophilic coating which becomes slippery when wet. On the opposing end of the shaft are a connecting funnel and a luer activated valve. This product is available in a combination of French sizes, balloon capacities and lengths to accommodate adult male and female applications. The device will be offered in French sizes from 14Fr to 26Fr, balloon size of 5 cc and 30cc, The device is disposable, sterile (Ethylene Oxide Sterilization) and for single use only.

The AMSINO® I.V. ADMINISTRATION SET is a device intended to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein.

The AMSINO® I.V. ADMINISTRATION SET is a single use, latex-free, Non-DEHP, gravity feed, sterile device sterilized with Ethylene Oxide Gas. It is used to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein. It is comprised of various components such as: bag, spike, drip chamber (vented and non-vented), Y-site, burette, tubing, flow controller, drip selector, clamp, check valve, latex-free injection site, needleless injection site, flashbulb, filter, manifold, stopcock, flash bulb, luer connectors and bag hanger. This submission is an extension of the original approval (k973107) and covers the following AMSINO Product Line: AMSINO® STANDARD I.V. ADMINISTRATION SET AMSafe® I.V. ADMINISTRATION SET (identical to the Amsino Standard I.V. Administration set, except it is marketed for Emergency Medical Services group/personnel) AMSafe3® I.V. ADMINISTRATION SET (identical to AmSafe I.V. Administration Set, with the exception of the drip selector option.) AMSINO offers both standard and custom sets with tubing of various sizes and lengths with a choice of 10, 15, 20 and 60 drops per ml to meet customer requirements and specifications. Customers may request I.V. Administration sets with varying configuration containing any combination of the parts per the table: Tubing Drip Chamber Needleless injection site Split Septum Injection Site Bag Spike Clamp Flow Controller Drip Selector Filter Rotating male luer lock Male or Female luer lock Check Valve Bag Hanger Y-site stopcock manifold

The AMSure ™ PVC Intermittent Catheter is intended for use in the drainage of urine from the bladder.

The AMSure ™ PVC Intermittent Catheter is a sterile, single- use patient device, compromising a PVC tubing and funnel.