Profile: Amsino International, Inc is an ISO 9001 certified company. We manufacture disposable medical products. We specialize in urology, general feeding with irrigation, IV therapy products, surgical, general & patient care products. Our capabilities include injection molding, extension, radiation, RF sedling & ultrasonic welding. Our surgical products include suction connecting tube, wound drainage suction reservoir, ear/ulcer syringe, suction yankauer, sterile suture removal kits, wound fluid collection bag, 5 in 1 connector and SIMS connector. Our IV start kit contains 1 alcohol prep pad, 1 2 x 2 inch gauze sponges, 1 patient id label, 1 pvp prep pad, 1 rl tape, 1 tourniquet, and 1 transparent dressing.

The company was founded in 1993, has revenues of USD 25-50 Million, has ~500 employees and is ISO 9001, CE certified.

FDA Registration Number: 2085175

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• Surgical Trays (FDA Code: LRP / 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.

• Surgical Trays (FDA Code: LRP / 878.4800)

• Suture Removal Kit (FDA Code: MCZ / 878.4800)

• Therapeutic Vaginal Douche Apparatus (FDA Code: HED / 884.5900) A therapeutic vaginal douche apparatus is a device that is a bag or bottle with tubing and a nozzle. The apparatus does not include douche solutions. The apparatus is intended and labeled for use in the treatment of medical conditions except it is not for contraceptive use. After filling the therapeutic vaginal douche apparatus with a solution, the patient uses the device to direct a stream of solution into the vaginal cavity.

• Three-Way Silicone Coated Latex Foley Catheter

• Tongue Depressors (FDA Code: FMA / 880.6230) A tongue depressor is a device intended to displace the tongue to facilitate examination of the surrounding organs and tissues.

• Tracheal Tube Fixation Device (FDA Code: CBH / 868.5770) A tracheal tube fixation device is a device used to hold a tracheal tube in place, usually by means of straps or pinch rings.

• Tracheal Tube with/without Connector (FDA Code: BTR / 868.5730) A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.

• 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.

• Ulcer Syringe

• Umbilical Occlusion Device (FDA Code: FOD / 880.5950) An umbilical occlusion device is a clip, tie, tape, or other article used to close the blood vessels in the umbilical cord of a newborn infant.

• Urinary Drainage Collection Kit (FDA Code: FCN / 876.5250) A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascent of infection. The two kinds of urine collectors are:

• Urinary Leg Bags

• Urine Collection Leg Bags (FDA Code: FAQ / 876.5250)

• Urine Collector and Accessories (FDA Code: KNX / 876.5250)

• Urine Leg Bags (FDA Code: FAQ / 876.5250)

• Urological Irrigation System (FDA Code: LJH / 876.5130)

• Urosheath Type Incontinence Appliance (FDA Code: EXJ / 876.5250)

• Vacuum Collection Bottle (FDA Code: KDQ / 880.6740) A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).

• Vaginal & Cervical Specula

• Vaginal Irrigation Set

• Ventilator Tubing and Support Set (FDA Code: BZO / 868.5975) Ventilator tubing is a device intended for use as a conduit for gases between a ventilator and a patient during ventilation of the patient.

• Venturi Low Concentration Oxygen Mask (FDA Code: BYF / 868.5600) A venturi mask is a device containing an air-oxygen mixing mechanism that dilutes 100 percent oxygen to a predetermined concentration and delivers the mixed gases to a patient.

• Vial Adapters

• Wheelchair Accessories (FDA Code: KNO / 890.3910) A wheelchair accessory is a device intended for medical purposes that is sold separately from a wheelchair and is intended to meet the specific needs of a patient who uses a wheelchair. Examples of wheelchair accessories include but are not limited to the following: armboard, lapboard, pusher cuff, crutch and cane holder, overhead suspension sling, head and trunk support, and blanket and leg rest strap.

• Wood ENT Tongue Depressor

• Wound Drainage Suction Reservoir

• Wound Fluid Collection Bag