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The RELIEEV HSG Catheter (HSG7FA1) is for the delivery of contrast media or saline into the uterine cavity during hysterosalpingography or sonohysterography for examination of the uterus and fallopian tubes.

The RELIEEV HSG Catheter (HSG7FA1) is a 7 French (Fr) dual lumen polyurethane catheter with a working length of 30 cm. RELIEEV HSG Catheter (HSG7FA1) is available with a closed-end tip with two side ports. The catheter consists of two lumens: an open lumen used to inflate the balloon and an open lumen used to inject diagnostic media into the uterus. The silicone balloon is designed with a balloon volume of 3.5 mL. When the balloon is inflated inside the uterus, the subject device seals the cervix. The catheter features a proximal fitting of a double-lumen polyurethane hub with a polycarbonate stopcock attached. Both the hub and stopcock accept a standard Luer lock. A stopcock is provided at the proximal end of the device to allow inflation of the balloon with a syringe. The center lumen is open through the device to the distal end, and the device has a luer connector at the proximal end for injecting fluids. An introducing sheath is placed over the tube as a guide and into the endocervix to the level of the internal os (opening of the cervix) with no dilatation required; therefore, allowing the catheter to pass easily through the cervix and into the uterine cavity.

The RELIEEV HSG Catheter (HSG7FA1) consists of a balloon catheter and a 5 mL syringe. The subject device is supplied sterile and is single-use.

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The Spectra Platinum is a single-user, powered breast pump intended to express and collect milk from the breasts of lactating women.

The Spectra Platinum is an electrically powered breast pump intended for use by lactating women to stimulate lactation and express breast milk. The device is intended for single-user, home use. Pumping can be performed on one breast (single pumping) or both breasts (double pumping) at the same time.

The Spectra Platinum operate using an AC adapter (100-240V AC, 50/60Hz, DC 12V) or a rechargeable Li-Polymer battery (11.1V, 2,000mAh).

The Spectra Platinum is comprised of the following components: Main unit, Power adapter, Tubing, Backflow protector, Wide breast shield, Milk bottle, Screw ring, Cap, Sealing cap for milk bottle, Silicone nipple, Silicone valve. The device is provided non-sterile.

The Spectra Platinum support a single pumping mode in which only one breast is expressed and a dual pumping mode in which both breasts are expressed. The user can switch between Massage Mode and Expression Mode using designated buttons and adjust the vacuum level and cycle speed within each mode.

Spectra Platinum includes the following features:

• Expression can be performed on one breast only (single mode), on both sides simultaneously (dual mode).
• Expression mode: 1-15 level (90-270 mmHg), cycle speeds (38, 42, 46, 50, 54)
• Massage mode: 1-5 level (60-100 mmHg), cycle speeds (70, 80, 90, 100, 105)

The Spectra Platinum operates within these specified parameters.

When the backflow protector is assembled between the pump unit and the wide breast shield, the silicone membrane inside the backflow protector creates a hygienic barrier by preventing air and milk from flowing back into the pump unit. This not only enables safe and hygienic breast pumping, but also protects the pump unit from contamination and potential damage caused by backflow of milk.

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The Lifestyles® HydraFeel Natural Rubber Latex Condom is used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted infections (STIs).

The LifeStyles® HydraFeel Natural Rubber Latex Condom is a single use condom made of natural rubber latex, featuring a straight-shaft, smooth-walled membrane that closely fits the penis. It acts as an barrier to prevent the transmission of sperm, bodily fluids, or STIs into the reproductive tract. The condom is coated with an aqueous lubricant and includes an integral bead at the open end for retention and a reservoir tip at the closed end to contain semen. The LifeStyles® HydraFeel Natural Rubber Latex Condom has a nominal length of 180 mm, width of 52 mm, and thickness of 0.045 mm. Each condom is packaged individually in laminate foils that are secondarily packaged in cardboard shelf boxes.

The device conforms with all sections of consensus standards ISO 4074:2015, Natural rubber latex male condoms – Requirements and test methods, and ASTM D3492-16, Standard Specification for Rubber Contraceptives (Male Condoms).

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The Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-) is a powered breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

The Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP434-, BP420-, BP431-, BP432-, BP400-) is a wearable powered breast pump intended to be used by lactating women to express and collect milk from their breast. The device is a non-sterile reusable device to be used by single user. The breast pump stimulates lactation and extracts milk from the breasts by creating a seal around the nipple and applying and releasing suction to the breast. The milk is collected in a milk collector. The device is electrically powered through a rechargeable Lithium battery (3.7V) that can be charged using the USB cable provided with the device.

The subject device includes three operating modes, namely - stimulation mode, expression mode, and mixed mode, with 15 levels of operation within each mode and a maximum suction of -315mmHg. In stimulation mode, the breast pump begins with a quick and short sucking pattern to get the milk to start flowing. In expression mode, the breast pump begins with a slow and long sucking pattern for milk expression, sucking more deeply and more slowly. In mixed mode, the breast pump begins with a quick and short sucking pattern, followed by a slow and long sucking pattern. The device features a diaphragm-type vacuum pump driven by a microprocessor. The microprocessor provides control over vacuum pressure and cycle speed during milk expression.

The pump remembers the mode and suction level settings. When restarted, it will resume with the same mode and suction level as when it was last turned off. Each mode's suction level setting is also remembered individually and remains consistent during future use.

The device can be connected wirelessly to a mobile device through Bluetooth and be operated through a dedicated mobile application (Mobile flow). By using the application, users can either select one of three preset operating modes or define a personalized mode. The personalized mode supports personalized sessions, each of which can select its own mode, suction level, and duration. Users can also enable a milk overflow reminder function in the app. Pumping output can also be recorded and tracked by users in the app.

The device is available in one or two pumps in a pack to allow for single/double pumping. The subject device includes an LED display that displays information regarding working mode, running time, suction level, battery status, full milk indicator and Bluetooth indicator. The user interface includes on/off/pause switch, mode selection switch, decrease pumping level, increase pumping level and Toggle button to select breast pump direction to left or right. The subject device includes a diaphragm to prevent milk backflow into the vacuum system as well as software based overflow protection.

The device includes a milk collection set that consists of the following: double-sealed flange (Polyphenylsulfone (PPSU) + Silicone), flange insert, diaphragm assembly, duckbill valve assembly, milk collector (Tritan) and main unit pump motor. Each component can be purchased separately by the user if needed.

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The Electric Breast Pump (Models HL-3058, F5112) is intended to express milk from lactating women and collect milk from their breast. The device is intended for single user.

The Electric Breast Pump (Models HL-3058, F5112) is an over-the-counter, non-sterile, single-user, powered breast pump intended to be used by lactating women to express and collect milk from their breasts. The device is intended for daily use in a home environment. The device uses a diaphragm-type vacuum pump driven by software embedded in the device to generate suction required to stimulate and express breast milk. The software provides control over vacuum pressure and cycle speed.
Electric Breast Pump (Models HL-3058, F5112) also has a hot function which provides hear to the users neck for warmth. It does not affect the intended use of the product.

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The Electric Breast Pump (Models HL-3060, F5113) is intended to express milk from lactating women and collect milk from their breast. The device is intended for single user.

The Electric Breast Pump (Models HL-3060, F5113) is an over-the-counter, non-sterile, single-user, powered breast pump intended to be used by lactating women to express and collect milk from their breasts. The device is intended for daily use in a home environment. The device uses a diaphragm-type vacuum pump driven by software embedded in the device to generate suction required to stimulate and express breast milk. The software provides control over vacuum pressure and cycle speed.

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The electric breast pump (models FZ-P8, YH-P8, YH-P8X) is a wearable electric breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

The electric breast pump (models FZ-P8, YH-P8, YH-P8X) is an electrical wearable breast pump powered by a rechargeable Li-ion battery. It consists of a Pump, Diaphragm, Cup, Valve, Silicone breast shield (flange) and dust cap:

The pump is the core component of the electric breast pump. It generates a cyclic negative pressure (vacuum) to simulate a baby's sucking motion, drawing milk from the breast into the collection system. The pump is electrically driven and controlled via a motor and control unit, typically offering adjustable suction levels and mode. The diaphragm separates the milk collection system from the pump mechanism, preventing breast milk from entering the pump motor and tubing. The cup is the container that collects and stores the expressed breast milk. The valve controls the one-way flow of breast milk. It opens and closes in sync with the suction cycles to allow milk to flow into the cup while preventing backflow. The silicone breast shield, also known as the flange, is the part that comes into direct contact with the breast. It creates a seal around the nipple and areola to enable effective suction. The dust cap covers the opening of the breast shield or milk collection port when the electric breast pump is not in use. It prevents dust, dirt, and other contaminants from entering the breast pump

The electric breast pump has 2 (Primary mode and secondary mode) x 3 modes (Massage Mode, Expression Mode, and Mixed Mode), each mode has 10 adjustable levels:

• Massage Mode provides a vacuum range of 40–190 mmHg and a frequency of 52–110 cycles per minute;
• Expression Mode provides a vacuum range of 80-280 mmHg and a frequency of 19–75 cycles per minute;
• Mixed Mode provides a vacuum range of 80-280 mmHg and a frequency of 6–63 cycles per minute.

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Uterine Aspiration Set is used with the vacuum system to aspirate transcervically the products of conception or menstruation from the uterus.

The Uterine Aspiration Set consists of rigid/flexible uterine aspiration curette and uterine aspiration tubing set(Composed of uterine aspiration tubing, swivel handle and other components). Rigid/flexible uterine aspiration curette and uterine aspiration tubing set(including uterine aspiration tubing and swivel handle) are all disposable and supplied sterile.

Rigid/Flexible Uterine Aspiration Curette
The rigid/flexible uterine aspiration curette is mainly used to scrape and remove tissues in the endometrium or uterine cavity. Its tip is suitable for entering the uterine cavity and performing scraping operations.

Uterine Aspiration Tubing Set
The uterine aspiration tubing set is mainly used to generate negative pressure during the surgical process. It is usually connected at one end to a Rigid/Flexible Uterine Aspiration Curette for scraping operations, and at the other end to a suction device, and tissues are sucked out by negative pressure. The suction force can be adjusted by sliding the ring on the vacuum control hole.

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COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS (light, regular, super, and super plus) are inserted into the vagina and used to absorb menstrual fluids.

The device is a conventional unscented menstrual tampon consisting of an organic cotton absorbent pledget ("absorbent core"), surrounded by an organic cotton cover ("security veil"), and an organic cotton string ("withdrawal cord"). It features a compact, polyethylene applicator. The inner and outer tubes slide into each other telescopically, so the inner tube must be retracted before use.

These tampons will be provided in four absorbencies: light (6g and under), regular (6-9g), super (9-12g) and super plus (12-15g). Each organic cotton compact applicator tampon is either individually wrapped with cellulose paper or polypropylene and packaged in sealed multi-unit containers for retail sale. The wrapped device can also be sold in bulk.

Device trade name COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS could be put into the market with various brands.

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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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