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For nasogastric oralgastric enteral feeding, incorporating safety connectors which eliminates the risk of IV administration through the feeding tube.

Nutrifit is a combined system of feeding tubes and extension sets. The feeding tubes are available in several configurations: Not made with DEHP PVC and Polyurethane (PUR). The PUR versions are available without stylet. All tubes include centimeter numerical markings from 5 to 35 cm for the 40, 50 and 75 cm feeding tubes and markings from 5 to 70 cm for the 90, 125 and 160 cm feeding tubes. The Nutrifit devices are single-use, disposable devices intention in adults and children. Nutrifit PVC feeding tubes are intended for enteral nutrition and for a short-term use, not longer than 5 days. Nutrifit PUR feeding tubes are intended for enteral nutrition and for a short-term use, not longer than 29 days. The Nutrifit accessories for this submission sets, which enable longer connections for the feeding tubes. They allow greater freedom of movement and greater flexibility and are available with or without a pinch clamp. Nutrift is ENFit compliant, meeting requirements for design and functional performance of small-bore connectors intended to be used for connections on enteral medical devices and accessories as detailed in ISO 80369-3.

Leaderflex mini and Leaderflex nano are indicated for: •Peripheral venous catheterization (midline) in any patient population with consideration given to the adequacy of vascular anatomy and appropriateness of procedure, or · Arterial catheterization

Leaderflex Mini and Leaderflex Nano are a radiopaque biostable polyurethane catheters suitable for peripheral venous catheterization (midline) in any patient population with consideration given to the adequacy of vascular anatomy and appropriateness of procedure. Leaderflex Mini and Leaderflex Nano catheters are inserted via Seldinger technique, same as the predicate device. The Leaderflex mini and Leaderflex nano catheters are intended to be used by clinicians such as nurses at in- and out-patient locations. The primary requirement for environment of use is to ensure the environment is appropriate for supporting aseptic technique. These catheters are typically inserted into a peripheral vein on the forearm or leg, with the catheter tip located below the axilla of the arm or below the groin of the leg; however, the catheter is not limited to these anatomical placement locations. This is the same environment of use and anatomical location as the predicate device. The subject Leaderflex Mini and Leaderflex Nano devices are accompanied by compatible accessories necessary to perform the Seldinger technique; these include: an introducer needle, guidewire, and guidewire insertion aid. The predicate Leaderflex device (K141026) is currently available in 22G configurations with usable lengths of 4cm, 6cm, 8cm and 20cm. The subject device will extend the device configurations to include 24G (Leaderflex Mini) and 26G catheters (Leaderflex Nano) with usable lengths of 2cm, 3cm, and 4cm and will add introducer needle and guidewires. The subject device also introduces a new guidewire insertion aid for all gauge sizes. The overall device description of the subject and predicate Leaderflex models is the same.

The catheters are indicated for short term access to the peripheral venous system intravenous therapies, blood sampling, and power injection of contrast media. These catheters may be used for any patient with consideration given to adequacy of vascular anatomy and appropriateness of the catheters are suitable for use with power injectors.

The Vygon Midline Catheters are EO sterilized, single-use, polyurethane, reverse taper, short-term, peripheral venous system access catheters. They include materials containing barium sulfate for radiopacity.

The catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injection of contrast media, and allow(s) for central venous pressure monitoring, infusion or therapy, use 4 French or larger catheter. The maximum recommended infusion rate is 5mL/section of contrast media. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.

The Vygon PICCs are sterile, single-use, polyurethane PICCs with the same intended use, indications for use, similar design, similar sizes, similar or the same materials, and similar properties as the predicate device.