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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• Medicine Spoon

• Microscope Slides (FDA Code: KEW / 864.3010) Tissue processing equipment consists of devices used to prepare human tissue specimens for diagnostic histological examination by processing specimens through the various stages of decalcifying, infiltrating, sectioning, and mounting on microscope slides.

• Microscope Slides (FDA Code: KEW / 864.3010)

• Nasal Oxygen Cannula

• Needleless I.V. Administration Sets

• Non Dental Irrigating Syringe (FDA Code: KYZ / 880.6960) An irrigating syringe is a device intended for medical purposes that consists of a bulb or a piston syringe with an integral or a detachable tube. The device is used to irrigate, withdraw fluid from, or instill fluid into, a body cavity or wound.

• Non-Mercury Thermometers

• Non-Metal Vaginal Speculum (FDA Code: HIB / 884.4530) An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:

• Non-Pneumatic Tourniquet (FDA Code: GAX / 878.5900) A nonpneumatic tourniquet is a device consisting of a strap or tubing intended to be wrapped around a patient's limb and tightened to reduce circulation.

• Non-Powered Portable Single Patient Suction Apparatus (FDA Code: GCY / 878.4680) A nonpowered, single patient, portable suction apparatus is a device that consists of a manually operated plastic, disposable evacuation system intended to provide a vacuum for suction drainage of surgical wounds.

• Non-Powered Sitz Bath (FDA Code: KTC / 890.5125) A nonpowered sitz bath is a device intended for medical purposes that consists of a tub to be filled with water for use in external hydrotherapy to relieve pain or pruritis and to accelerate the healing of inflamed or traumatized tissues of the perianal and perineal areas.

• Non-Sterile Absorbent Tipped Applicator (FDA Code: KXF / 880.6025) An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic stick. The device is used to apply medications to, or to take specimens from, a patient.

• Non-Sterile Device, Paste-On For Incontinence (FDA Code: NOA / 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:

• Non-Sterile Leg Urine Collection Bag For External Use (FDA Code: NNW / 876.5250)

• Non-Sterile Specimen Container (FDA Code: NNI / 864.3250) A specimen transport and storage container, which may be empty or prefilled, is a device intended to contain biological specimens, body waste, or body exudate during storage and transport in order that the matter contained therein can be destroyed or used effectively for diagnostic examination. If prefilled, the device contains a fixative solution or other general purpose reagent to preserve the condition of a biological specimen added to the container. This section does not apply to specimen transport and storage containers that are intended for use as part of an over-the-counter test sample collection system for drugs of abuse testing.

• Non-Surgical Tongue Depressor (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.

• Operating Room Scrub Brush (FDA Code: GEC / 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.

• Oxygen Masks (FDA Code: BYG / 868.5580) An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols.

• Oxygen Nasal Cannula (FDA Code: CAT / 868.5340) A nasal oxygen cannula is a two-pronged device used to administer oxygen to a patient through both nostrils.

• Pediatric (Enteral) Feeding Kit (Tube, Food, Nutrition, Oral, Infant)

• Pediatric Urine Collector (FDA Code: KNX / 876.5250)

• 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.

• Preconnected Urethral Catheterization Tray

• Pressure Fluid Displacement Valve

• Pvc Intermittent Female Catheters

• Red Rubber Urethral Catheter

• Reservoir Bag (FDA Code: BTC / 868.5320) A reservoir bag is a device, usually made of conductive rubber, intended for use in a breathing circuit as a reservoir for breathing gas and to assist, control, or monitor a patient's ventilation.

• Reusable Leg Bags

• Scalpel Blade (FDA Code: GES / 878.4800)

• Silicone Elastomer, Coated Latex Foley Catheters

• Silicone Elastomer-Coated Latex Foley 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.

• Split Septum Administration Sets

• Standard Burette Sets

• Standard I.V. Administration Sets

• Sterile Absorbent Tipped Applicator (FDA Code: KXG / 880.6025)

• Sterile Irrigating Syringe

• Sterile Irrigation Syringe

• Sterile Irrigation Tray (FDA Code: EYN / 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).

• Sterile Leg Urine Collection Bag for External Use (FDA Code: FAQ / 876.5250)

• Sterile Paste-On Incontinence Device (FDA Code: EXI / 876.5250)

• Sterile Specimen Container (FDA Code: FMH / 864.3250)

• Sterile Specimen Trap (FDA Code: BYZ / 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).

• Sterile Suture Removal Tray

• Sterile Urethral Catheterization Kit (FDA Code: FCM / 876.5130) A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudecatheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

• Suction Catheter and Tip (FDA Code: JOL / 880.6740)

• Suction Catheter Kit with One Glove

• Suction Connecting Tubes

• Suction Yankauer

• Surgical Razor (FDA Code: LWK / 878.4800)