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The UTAH CVX-RIPE™ is intended to mechanically improve the favorability of the cervix of pregnant patients at term gestation, in which induction of labor is medically indicated.

The UTAH CVX-RIPE™ is a double balloon catheter. The tip is placed through the vagina and into the cervical canal. The distal balloon is positioned against the internal cervical os and inflated with saline. The proximal balloon is positioned against the external cervical os and inflated with saline, providing gradual mechanical cervical dilation by simultaneously applying pressure on the internal and external cervical os. The materials used to manufacture the device, and which have patient contact, are all medical grade silicone. The UTAH CVX-RIPE™ consists of an 18 Fr., 42 cm silicone catheter with a silicone tip and two silicone balloons. Each balloon is independently inflated via a separate inflation lumen through color coded check valves located at the proximal end of the device. The check valves are marked accordingly, "U" for the distal uterine balloon and "V" for the proximal vaginal balloon. A malleable stainless steel stylet is included for ease of placement. The stylet is placed through a third separate lumen that is closed at the distal tip. The stylet is preloaded in the catheter.

The FINESSE+ and FINESSE II+ are intended to deliver high frequency electrical current for surgical procedures that can be performed with monopolar cutting and/or coagulation of tissue. One intended use of the FINESSE+ and FINESSE II+ systems is Loop Excision of the Transformation Zone (LETZ®).

The Finesse 3rd Generation combines a high-quality, class I type BF electrosurgical generator and a smoke evacuation system into a single compact unit. This integrated system is designed to perform low-power excision and coagulation procedures of short duration. The Finesse 3rd Generation is comprised of two models: FINESSE+ and FINESSE II+. The FINESSE II+ is identical to the FINESSE+, but does not have as many user adjustable features.

BT-Cath (BTC-100) is intended to provide temporary control or reduction of uterine bleeding during postpartum hemorrhage that is unresponsive to standard therapy including massage and oxytocin administration.

The BT-Cath consists of an extruded silicone dual lumen catheter with an inflatable molded silicone tamponade balloon attached on the distal end. One lumen of the catheter serves as the conduit through which saline is infused into the balloon after insertion into the bleeding uterus. When inflated properly to press against the uterine wall, the balloon provides compression against multiple sites of torn arteries, ruptured sinuses, lacerations and other tissue evoking hemorrhage. The second lumen, which is open at the distal end of the catheter, provides a drainage port for blood and other bodily fluids. At the proximal end of the catheter, a stopcock retains the saline in the balloon until a clinician gradually drains it allowing the uterus to contract. For ease of filling the balloon with multiple syringes, a check valve is also provided at the proximal end. The device is latex-free and provided sterile.

TVUS/HSG-Cath™ is intended for intracervical injection of saline into the uterus for enhanced transvaginal ultrasonography (TVUS), also known as saline infusion sonography (SIS). TVUS/HSG-Cath may also be used for the delivery of contrast media into the female reproductive tract for diagnostic examination of the uterus and fallopian tubes. TVUS (SIS) with saline infusion: - persistent abnormal or dysfunctional uterine bleeding . - suspected myometrial or intraluminal abnormalities (e.g., . fibroids or polyps) - . thickened or irregular endometrium - recurrent pregnancy loss t - pre- and post-operative assessment of uterine pathology . HSG with contrast media: - unexplained infertility . - recurrent pregnancy loss

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The Irrigation/Aspiration/Coagulation Electrodes, ICE-311 and ICE-511, are indicated for electrosurgical fulguration (coagulation) of the uterine cervix as part of the procedure called Loop Excision of the Transformation Zone (LETZ®), or other loop electrosurgery procedures where simultaneous electrosurgical fulguration and small-volume fluid irrigation and/or aspiration is needed.

The device consists of a stainless steel spherical ball electrode attached to an ULTEM® irrigation and aspiration head that has PVC irrigation and aspiration tubes. The posterior end of the electrode shaft fits snugly into a standard electrosurgical pen which is connected to an electrosurgical generator that has been cleared for marketing by the FDA. The irrigation tube has a PVC female Luer fitting for connection to a fluid source and the aspiration tube has an ABS suction adapter for connection to a standard vacuum suction system.

This device is intended as therapeutic aid in the conservative treatment of stress incontinence, urge incontinence or mixed stress and urge incontinence in women. Patients appropriate for this therapy should be selected using the following criteria: Indications: - Good general health, both mentally and physically. . - Urge incontinence due to detrusor instability or of idiopathic origin. . - Stress incontinence not associated with intrinsic sphincter deficiency. ● - Mixed incontinence. . - Ability of patient to understand and demonstrate understanding of the use of the Liberty Plus . System. - . Willingness to comply with the therapy plan. Contraindications: - Use of a cardiac pacemaker, or a history of rate or conductive disturbances. . - Neurological deficiency that would not permit proper sensory perception or stimulation. . - . Currently pregnant or attempting to get pregnant. - Anatomical vaginal structure that does not permit proper and complete placement of the . vaginal probe. - . Irregular menstrual bleeding cycles. - Any urinary or vaginal infections, localized lesions or other undiagnosed symptoms. . - . History of urinary retention or current symptoms.

The device consists of a hand held electrostimulation unit and an injection molded thermoplastic applicator that supports two stainless steel electrode rings that apply electrical stimulation to a patient in order to help train neuromuscular tissue in the pelvic floor for improvement or restoration of urinary continence for women. The applicator includes a pressure transducer that provides biofeedback relations of the pelvic floor muscles. The electrical stimulation energy and the power for the transducer are conducted to the electrodes via a six conductor cable and connector that plugs into the PFS-300. The transducer output signal is conducted back to an LCD graphical display by the same cable. The PFS-300 is indicated for use to help train the pelvic floor muscles using electrical stimulation and biofeedback. The PFS-044 is a vaginal applicator that is used with the PFS-300. The PFS-300 is a battery powered electrostimulation device that applies electrical stimulation through electrodes on the PFS-044 applicator.

The ABC ("Arterial Blood Collection") In-Line Blood Sampling Kit is a closed blood sampling system used in conjunction with continuous blood pressure monitoring in a critical care setting. The ABC Kit is designed for use with all disposable and reusable pressure transducers and for connection to central line catheters and arterial catheters. The ABC Kit is used for the drawing and retention within the line of heparinized blood from the catheter/cannula, allowing undiluted blood samples to be drawn from an in-line sampling site. At the completion of sample drawing, the mixed heparin/blood solution is reinfused into the patient to reduce fluid loss.

The ABC ("Arterial Blood Collection") In-Line Blood Sampling Kit is a closed blood sampling system used in conjunction with continuous blood pressure monitoring in a critical care setting. The ABC Kit is designed for use with all disposable and reusable pressure transducers and for connection to central line catheters and arterial catheters. The ABC Kit is used for the drawing and retention within the line of heparinized blood from the catheter/cannula, allowing undiluted blood samples to be drawn from an in-line sampling site. At the completion of sample drawing, the mixed heparin/blood solution is reinfused into the patient to reduce fluid loss.

The PFS-043 is indicated for use to help train the pelvic floor muscles using electrical stimulation. The PFS-043 is a rectal applicator that is used with the UMP Liberty PFS System (PFS), which is a battery powered electrostimulation device that applies electrical stimulation through electrodes on the applicator.

The device consists of an injection molded thermoplastic applicator that supports two stainless steel electrode rings that apply electrical stimulation to a patient in order to help train neuromuscular tissue in the pelvic floor for improvement or restoration of urinary continence in men and women. The electrical stimulation energy is conducted to the electrodes via a two conductor cable and connector that plugs into the Liberty Stimulator.