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The Kiwi Complete Vacuum Delivery System (Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S)) is indicated for use in the following conditions:

• Prolonged second stage of labor (arrest of descent) where fetopelvic relationships are adequate
• Presumed fetal jeopardy that is not considered to be severe
• Elective shortening of the second stage for selected maternal or fetal conditions

The subject device is a fetal vacuum extractor (Kiwi® Complete Vacuum Delivery System) that includes four different models: OmniCup® (VAC-DUAL M); OmniCup® with Traction Force Indicator (VAC-DUAL MT); OmniC Cup® for Cesarean Section (VAC-DUAL C); ProCup® (VAC-DUAL S). All models use the same pump assembly, which allows the user to generate vacuum by squeezing the handle repeatedly. The pump/handle assembly includes a vacuum gauge that is color-coded to indicate safe operating pressures for the device. Models M and MT differ only in the inclusion of a traction force indicator (MT). Model C differs from models M/MT in the cup design, which has a lower profile cup with finger grooves to facilitate use in cesarean sections, as well as a baffle instead of an inner filter. The model S design is suggested for use in vaginal births and includes a combined tube and cup portion that is flexible and fits over the fetal head.

For vaginal delivery, the device is operated by inserting the cup into the vagina and placing the cup at the flexion point on the fetal skull. The Omni-C is designed specifically for the confined abdominal space of C-section deliveries. It is designed with a slimmer cup profile, finger grooves and baffle filter on the inside. For cesarean delivery, the cup is inserted into the incision over the flexion point.

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The GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device is intended to be inserted transvaginally to establish a path of entry for minimally invasive instruments and maintain insufflation during laparoscopic-assisted and vaginal gynecological procedures. The device may be used for sentinel pelvic lymph node dissection occurring in the retroperitoneal space. The device is also a conduit for the extraction of specimens

The GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device consists of an intraperitoneal Alexis retractor and retroperitoneal Alexis retractor that are placed transvaginally to create a pathway to the peritoneum and retroperitoneum. A GelSeal cap attaches to the retractors at the opening of the vagina. The cap allows for insufflation and smoke evacuation. Sleeves inserted through the cap allow for passage of 5mm to 12mm laparoscopic instrumentation. Visualization is achieved via introduction of an endoscope through a sleeve. The device is provided sterile.

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Hi bebe super (BT-150B) is intended to be used by lactating women for expressing and collecting breast milk. It is intended for a single user.

The Hi bebesuper (model: BT-150B) is an electrically powered, software-controlled breast pump intended to express and collect milk from the breast of lactating women. The breast pump system is comprised of a motor unit and pump kit including tubing.

BT-150B electrical breast pump is intended to be used by a single user. The user has the option to pump breast milk from a single breast (single pumping) or from both breasts (double pumping). BT-150B electrical breast pump also includes back flow protection and it is powered by a 12V DC adaptor or rechargeable lithium battery.

BT-150B electrical breast pump has three operating modes: massage mode, expression mode and program mode to save pressure level and cycle level and their mode (massage or expression) and their running time. Sixteen (16) vacuum pressure levels are available for operating mode ad massage mode. One cycle speed level is available for massage mode and three (3) cycle speed levels are available for expression mode. The device is capable of providing suction up to -270 mmHg.

The subject device is a modified version of BT-150S model of K200675. Compared to the predicate device, the following changes are made.

• Power source change. Both AC-powered mode and battery-powered mode are available.
• Vacuum pressure and cycle speed.
• User interface: Compared to the predicate device, the lamp button is removed, increase cycle speed button and decrease cycle speed button are combined as one cycle level change button, and the function of each button is modified.
• Dual motors system: The subject device includes dual pumps while the predicate device includes a single pump. Compared to the predicate device, a sub board has been removed and both pumps are connected to the main board.

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Polyvinyl Alcohol Embolic Microspheres are intended to be used for the embolization of arteriovenous malformations (AVMs) and hypervascular tumors, including uterine fibroids.

The subject device polyvinyl alcohol embolic microspheres are compressible hydrogel microspheres with a regular shape, smooth surface, and calibrated size, which are formed as a result of chemical modification on polyvinyl alcohol (PVA) materials. The embolic microspheres consist of a macromer derived from polyvinyl alcohol (PVA) and are hydrophilic, non-resorbable. The preservation solution is 0.9% sodium chloride solution.

The polyvinyl alcohol embolic microspheres available in dyed (blue) and clear (undyed with natural color). The subject device available in particle sizes from 75-1200μm and supplied sterile in sterile sealed glass vials which contain 1 mL, 2 mL, or 3 mL of microspheres suspended in 7mL, 7mL, or 6 mL of 0.9% sodium chloride solution, respectively.

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