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The EUM100Pro (Electro Uterine Monitor) is a transabdominal electromyography (EMG) monitor intended to non-invasively measure intrapartum uterine activity. The EUM100Pro acquires the signal from surface EMG electrodes placed on the patient abdomen. The EUM100Pro is intended for use on women in term (>36 completed weeks of gestation) labor, with singleton pregnancies. The EUM100Pro is intended for use by healthcare professionals in a clinical setting.

The EUM100Pro System is designed to present and record the electrical activity of the uterus. The activity is shown as graphs similar to the commonly use toco-dynamometer. The EUM100Pro is built around an EN- 60950 certified computer. Analog signals are obtained from CE certified amplifier box from Delsys Inc., Boston, MA. Delsys also supply the input modules, power supply, electrodes and disposable stickers. The system is comprised of a multi-channel surface electromyogram operative to sense electromyographic (EMG) activity, a three-dimensional position sensor and a personal computer providing data analysis, recording media and a graphical user interface.

The ClearPath Tubing is intended to provide irrigation fluids, such as water, during gastrointestinal endoscopic procedures when used in conjunction with the ClearPath irrigation system components (ClearPath Lower GI, ClearPath Upper GI, and ClearPath Irrigator).

The ClearPath Tubing is intended to provide irrigation fluids, such as water, during gastrointestinal endoscopic procedures when used in conjunction with the ClearPath irrigation system components (ClearPath Upper GI, ClearPath Lower GI, and ClearPath Irrigator). The ClearPath Tubing is single use, disposable. The ClearPath irrigation system is designed to improve procedure reliability by improving visualization during endoscopic procedures by performing a colon or stomach wash. The ClearPath Tubing is used to connect the irrigation fluid source (i.e. water bottle), via the peristaltic pump, to the cleaning device of the ClearPath product family (ClearPath Lower GI, K091305 and K113050, ClearPath Upper GI, K093779 and K113166, and ClearPath Irrigator, K 101094). Note that only the ClearPath accessories are to be used with the ClearPath Tubine.

A non-IV connector for use with Infant Feeding tubes that are intended to be placed into the stomach to permit the introduction of fluids as directed by the physician. Intended for nasogastric or orogastric placement. Limited to < 30 day placement. Not intended for transpyloric placement.

The proposed modification to Infant Feeding Tube is to change the fittings from a standard slip fit luer to a non-IV (luer) size connector. The feeding tubes are a small diameter tube of various diameters, 5, 6, and 8 French, and lengths, 14.5", 35" and 41". It has an integral female luer fitting. There are 2 eyelets near the tip of the tube. It has marking along the shaft of the tubing and an integral radiopaque line. It is provided sterile. We will offer a non-sterile syringe with the appropriate mating, non-IV connector as part of a kit.

The BabyAir™ is a pneumatic nebulizer, UDN, with a hood, which nebulizes specific drugs for inhalation by a patient. The patient population includes infants. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a nebulizer. This product is a single patient, multi- use, non-sterile prescriptive device. It is intended to be used in either a hospital or homecare environment.

The BabyAir™ is comprised of: Transparent Hood Covering shield draped over a plastic base. Nebulizer Assembly - The Nebulizer converts the liquid medication into a fine aerosol mist and directs the aerosol toward the infant efficiently and safely. Compressor Not included. Any standard nebulizer compressor which has an operating flow rate range of 8 to 11 Lpm at no back pressure or has a pressure of 3 bar under a no flow conditions, may be used.

The Infant Feeding tube is intended to be placed into the stomach to permit the introduction of fluids as directed by the physician. Intended for nasogastric or orogastric placement. Limited to < 30 day placement. Not intended for transpyloric placement.

The Infant Feeding Tube is a small diameter tube of various diameters, 5, 6, and 8 French, and lengths, 14.5", 35" and 41". It has an integral female luer fitting. There are 2 eyelets near the tip of the tube. It has marking along the shaft of the tubing and an integral radiopaque line. It is provided sterile.

For use in a kit for nerve blocks or wound site pain management. To provide continuous or intermittent delivery of local anesthetics or other medications to surgical wound sites and/or close proximity to nerves outside the epidural space. Routes of administration may be intraoperative or percutaneous. As an accessory to Sorenson medical infusion pumps or as a standalone device, but not for use with gravity feed. Single patient use only.

The infusion catheter is a small bore, 20 gauge, tube with holes at the tip to permit dispersion of the modication into the site. The overall cather is 30" in length with various lengths of holes (fenestrations) of - 1.5", 3.0", and 5.0" with a standard Touly Borst connector. The catheter has markings on the shaft to provide a reference guide for the clinician. May be available in a kit. Provided stcrilc.

The gas sampling lines are intended to connect to a port in the breathing circuit to the expired gas monitor. Disposable, single use.

Small bore tubing of various internal diameters and lengths, commonly referred to as gas-sampling lines. These connect to a port in the breathing circuit. May incorporate standard luer connector fittings and / or in-line filter at monitor end.

The Infant Feeding tube is intended to be placed into the stomach to permit the introduction of fluids as directed by the physician. Intended for nasogastric or orogastric placement. Limited to less than 30 day placement. Not intended for transpyloric placement.

The Infant Feeding Tube is a small diameter tube of various sizes - 5,6, and 8 French, and lengths of 14.5", 35" and 41". It has an integral female luer fitting. There are 2 eyelets near the tip of the tube. It has marking along the shaft of the tubing and an integral radiopaque line. It is provided sterile.