Profile: Utah Medical Products Inc manufactures & markets a broad range of disposable and reusable specialty medical devices. Our products include arterial blood collection, blood pressure monitoring accessories, blood pressure monitoring components, neonatal blood filtration, dissection electrodes, electrosurgical generators & instruments, uterine manipulation, chest drainage, enteral feeding, lumbar puncture, palate protection, peritoneal dialysis, urinary drainage, and umbilical catheterization. The Uri-Cath™Urinary Catheter Set consists of a pre-connected silicone urinary drainage catheter, three way stopcock for sampling purposes, and a 150 ml burette for accurate urine output measurement. Our Intran® Plus is the original transducer-tipped intrauterine pressure catheter (IUPC), assuring the accurate measure of uterine pressure contraction intensity throughout the rigors of labor and delivery. Our AROM-Cot® is a non-latex digital amniotomy device that does not compromise patient confidence and relaxation during the artificial rupture of membranes. Our Finesse® and Finesse® II electrosurgical generator & smoke evacuation systems are designed to meet the high performance & safety standards required for loop electrosurgery procedures. Our Gesco™Umbili-Cath™ is a single, dual and triple lumen umbilical vein/artery catheters that allow continuous pressure monitoring while administering medications, volume expanders & antibiotics.

The company was founded in 1978, has revenues of USD 25-50 Million, has ~220 employees and is ISO 9000, ISO 9001, CE certified. NASDAQ:UTMD (SEC Filings)

FDA Registration Number: 1718873

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• Active Electrosurgical Electrode (FDA Code: FAS / 876.4300) An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

• Amniotome (FDA Code: HGE / 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:

• Arterial Blood Collection Systems

• Arterial Blood Sampling Kit (FDA Code: CBT / 868.1100) An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. The kit may include a syringe, needle, cork, and heparin.

• Battery-Powered Endoscope and Accessories (FDA Code: GCS / 876.1500) An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

• Battery-Powered Medical Examination Light (FDA Code: KYT / 880.6350) A battery-powered medical examination light is a battery-powered device intended for medical purposes that is used to illuminate body surfaces and cavities during a medical examination.

• Blood Bag Spikes

• Blood Pressure Monitoring Accessories

• Blood Pressure Monitoring Components, Fluid Administration Sets

• Blood Pressure Monitoring Components, Pressure Tubing

• Blood Pressure Monitoring Components, Stopcocks

• Blood Pressure Monitors

• Blood Transfusion Microfilter (FDA Code: CAK / 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 Adaptor (FDA Code: DTL / 870.4290) A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.

• Catheter Repair Kits

• Chest Drainage Catheters

• Condom, Contraceptive (FDA Code: HIS / 884.5300) A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of venereal disease). The device may also be used to collect semen to aid in the diagnosis of infertility.

• Continuous Flush Catheter (FDA Code: KRA / 870.1210) A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.

• Continuous Irrigation Catheter (FDA Code: GBQ / 878.4200) An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

• Diagnostic Spirometer (FDA Code: BZG / 868.1840) A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.

• Disposable Mushroom-Shaped Vacuum Delivery Cups

• Disposable Polyethylene Bell-Shaped Vacuum Delivery Cups

• Disposable Pressure Transducers

• Disposable Silicone Bell-Shaped Vacuum Delivery Cups

• Disposable Surgical Instrument Kit (FDA Code: KDD / 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.

• Drainage Catheter

• Electrode Cables (FDA Code: IKD / 890.1175) An electrode cable is a device composed of strands of insulated electrical conductors laid together around a central core and intended for medical purposes to connect an electrode from a patient to a diagnostic machine.

• Electrosurgical Accessories, Dispersive Pads

• Electrosurgical Accessories, Smoke Evacuator Conversion Kits

• Electrosurgical Cutting and Coagulation Device (FDA Code: GEI / 878.4400) An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

• Electrosurgical Pens

• Electrosurgical Scalpels

• Endometrial Suction Curette and Accessories (FDA Code: HHK / 884.1175) An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include catheters, syringes, and tissue filters or traps.

• Endoscopic Irrigation, Endoscopic Bulb Irrigators

• Extravascular Blood Pressure Transducer (FDA Code: DRS / 870.2850) An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.

• Fetal Heart Rate Monitoring System

• Fetal Vacuum Extractor (FDA Code: HDB / 884.4340) A fetal vacuum extractor is a device used to facilitate delivery. The device enables traction to be applied to the fetal head (in the birth canal) by means of a suction cup attached to the scalp and is powered by an external vacuum source. This generic type of device may include the cup, hosing, vacuum source, and vacuum control.

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

• General & Plastic Surgery Pediatric Catheter (FDA Code: GBN / 878.4200)

• Generators

• Gynecologic Electrocautery and Accessories (FDA Code: HGI / 884.4120) A gynecologic electrocautery is a device designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation. This generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables.

• Gynecological Electrodes

• Infant Aspirator

• Infant Oxygen Hood (FDA Code: FOG / 868.5700) A nonpowered oxygen tent is a device that encloses a patient's head and upper body to contain oxygen delivered to the patient for breathing. This generic type of device includes infant oxygen hoods.

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

• Intrauterine Catheter and Introducer (FDA Code: HGS / 884.2700) An intrauterine pressure monitor is a device designed to detect and measure intrauterine and amniotic fluid pressure with a catheter placed transcervically into the uterine cavity. The device is used to monitor intensity, duration, and frequency of uterine contractions during labor. This generic type of device may include the following accessories: signal analysis and display equipment, patient and equipment supports, and component parts.

• Intrauterine Pressure Monitor (FDA Code: KXO / 884.2700)

• Intrauterine Pressure Monitor Interface Cables

• Intrauterine Pressure Transducer (FDA Code: HFN / 884.2700)

• Labor and Delivery Kit (FDA Code: MLS / 884.4530)