Vygon Corp.

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Contact: John A. Leaity - VP
Web: http://www.vygonusa.com
E-Mail:
Address: 2495 General Armistead Avenue, Norristown, Pennsylvania 19403-3685, USA
Phone: +1-(610)-539-9300, 800-544-4907 | Fax: +1-(610)-539-9333 | Map/Directions >>

Profile: Vygon Corp. deals with single-use medical and surgical products. Our neonatal & pediatric special care products are categorized as vascular access, digestive tract and respiratory tract. The PremiCath is a 27G (1.1 Fr) Flexane® catheter for mid-long term I.V.therapy. Its 24G splitting introducer needle allows easy cannulation of the peripheral veins and features a transparent hub, which enables early detection of blood flashback. It features an integral extension, reducing the risk of catheter-related infections. Our Nutrisafe2 connection is an enteral feeding tube. Being a complete system, it does not change the technique of the clinical staff and therefore does not require special training. It cannot be connected to a standard luer fitting, thus eliminating the risk of accidental connection of an enteral system to an I.V. system.

The company was founded in 1962, has revenues of USD 50-100 Million and is ISO 9001, CE certified.

FDA Registration Number: 2245270

32 Products/Services (Click for related suppliers)

• Amphetamine Enzyme Immunoassay Test (FDA Code: DKZ / 862.3100)

An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.

• Anesthetic Infusion Pump (FDA Code: FRN / 880.5725)

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

• Blood Collection Lancet (FDA Code: FMK / 878.4800)

A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

• Blood Exchange Transfusion Trays

• Blood Transfusion Sets (FDA Code: BRZ / 880.5440)

An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

• Cardiopulmonary Bypass Vascular Catheter (FDA Code: DWF / 870.4210)

A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.

• Control Suction Catherters

• Double Lumen Umbilical Catheters

• Dual Lumen Catheter

• ECC Catheters

• Endotracheal Tubes

• Feeding Tubes (FDA Code: FPD / 876.5980)

A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).

• Fluid Delivery Tubing (FDA Code: FPK / 880.5440)

• Gastrointestinal Tube and Accessories (FDA Code: KNT / 876.5980)

• I.V. Container (FDA Code: KPE / 880.5025)

An I.V. container is a container made of plastic or glass used to hold a fluid mixture to be administered to a patient through an intravascular administration set.

• I.V. Fluid Transfer Unit (FDA Code: LHI / 880.5440)

• Infusion Line Filter (FDA Code: FPB / 880.5440)

• Intravenous Administration Kit (FDA Code: FPA / 880.5440)

• Methamphetamine Gas Chromatography Test (FDA Code: LAF / 862.3610)

A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.

• Pediatric Products

• Peristaltic Infusion Pump (FDA Code: FRN / 880.5725)

• Piston Syringe (FDA Code: FMF / 880.5860)

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

• Short-Term Less Than 30 Days Therapeutic Intravascular Catheter (FDA Code: FOZ / 880.5200)

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

• Single Lumen Catheters

• Single Lumen Hypodermic Needle (FDA Code: FMI / 880.5570)

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

• Single Lumen Umbilical Catheters

• Stopcock, I.V.Set (FDA Code: FMG / 880.5440)

• Suction Catheter

• Therapeutic Intravascular Catheter (FDA Code: LJS / 880.5970)

A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.

• Tracheal Suction Catherters

• Tracheobronchial Suction Catheter (FDA Code: BSY / 868.6810)

A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway.

• Umbilical Catheter