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The Paruu Wearable Breast Pump 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 Paruu Wearable Breast Pump is a powered breast pump intended to be used by lactating women to express and collect milk from their breast in home healthcare environment. 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 breast milk is collected in a milk collector. The device consists of a pump motor (main unit), milk collection set (flange, diaphragm, duckbill valve, milk collector, flange cover) and accessories (flange insert, charging cable). The milk collection set and flange insert can be purchased separately.

The device uses a diaphragm-type vacuum pump driven by a microprocessor. The microprocessor provides control over vacuum pressure and cycle speed. The user interface consists of buttons allowing the user to switch between modes and control the vacuum pressure levels, and LED display that providing information on current mode, level, timer and battery status.

The device includes 23 different models, and based on their technological characteristics, are divided into two broad categories – P16 series consisting of models P16, P16-A, P16-B, P16-C, P16-D, and P20 series consisting of models P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D. The models within each series vary in terms of their external color. All device models include 4 working modes (Stimulation, Expression, Two-in-one and Dual frequency for P16 Series and Stimulation, Expression, Lactation, and Traction for P20 Series) and 12 suction levels for each mode.

To prevent milk from flowing into the vacuum system, the milk collection set includes a diaphragm that physically separates the milk-contacting pathway from the vacuum system. The motor unit operates on 3.7V rechargeable lithium battery. The rechargeable battery can be charged from the external power adapter (not included with the device) through the provided charging cable. All milk contacting components of the device are compliant with 21 CFR 177.

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Chiavaye personal moisturizer is a lubricant for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Chiavaye personal moisturizer is not compatible with natural rubber latex, polyurethane, or polyisoprene condoms.

Chiavaye Personal Moisturizer is a clear to slightly yellow and odorless oil-based personal lubricant that is not compatible with condoms made of natural rubber latex, polyisoprene, or polyurethane. This device is a non-sterile personal lubricant for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.

This device is sold as an over-the-counter (OTC) product in 30 mL and 100 mL sizes provided in black 'MIRON' glass, with a Polypropylene (PP) protective cap. The pump cap is made of Polypropylene (actuator), Nitrile (seal), and Polyethylene (tube).

The device is composed of Almond Oil, Coconut Oil, Grape Seed Oil, Sunflower Oil, Evening Primrose Oil, and Vitamin E.

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The Electric Breast Pump (Model YM-8807, YM-8805, YM-8806 and YM-8810) 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 Electric Breast Pump (Models YM-8807, YM-8805, YM-8806 and YM-8810) is a powered breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is provided non-sterile and is reusable device intended for a single user in home healthcare environment.

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 uses a diaphragm-type vacuum pump driven by a microprocessor. The microprocessor provides control over vacuum pressure and cycle speed. The motor unit operates on a rechargeable Lithium battery (3.7V/1400mAh). The rechargeable battery can be charged from the external power adaptor specified in the User Manual (not included) through the provided USB charging cable. The user interface features four buttons (power, mode selection, vacuum level increase and decrease) and an LED display (current mode, level, timer and battery status), allowing the user to navigate between modes and adjust the vacuum pressure.

The subject device includes four models that have same working principle and technology but differ in terms of their appearance, components, and materials. All device models have three modes of operation: Stimulation phase, Expression phase, Simulated sucking Phase, with nine levels in each mode. The Stimulation phase provides high cycle frequency and gentle suction, while the Expression phase provided slower cycles with higher vacuum pressures. The Simulated sucking phase provides a combination of the other two phases - two cycles in Expression phase followed by one Stimulation phase cycle, then three Expressions phase cycles followed by two in Stimulation phase to form one cycle.

To prevent milk from flowing into the vacuum system, the milk collection set includes a diaphragm that physically separates the milk-contacting pathway from the vacuum system. All milk contacting components of the device are compliant with 21 CFR 177.

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The Wearable electric breast pump (Model: YM-8803) 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 Wearable electric breast pump (Model YM-8803) 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 device is provided not sterile and should be cleaned and disinfected according to the instructions for use.

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 container.

The device uses a diaphragm-type vacuum pump driven by a microprocessor. The microprocessor provides control over vacuum pressure and cycle speed.

To prevent milk from flowing into the vacuum system, the milk collection set includes a diaphragm that physically separates the milk-contacting pathway from the vacuum system. The motor unit operates on a rechargeable battery. The rechargeable battery can be charged from the external power adaptor specified in IFU (not included) through the provided USB charging cable. The user interface features four buttons and an LED display, allowing the user to navigate between modes and adjust the vacuum pressure.

The subject device has two modes: Stimulation and Expression.

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ARMI® Hysteroscopy System 2.0 is intended to be used for viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures.

The ARMI® Hysteroscopy System 2.0 (subject device) is a hysteroscope and compatible accessories consisting of the following components:

• ARMI® Endoscopic Video Image Processor (non-sterile, reusable), JY-MIP-3000
• ARMI® Single-Use Hysteroscope (sterilized with ethylene oxide), SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C
• Disposable Electronic Hysteroscope (sterilized with ethylene oxide) (510(k) cleared under K210270),
• Power cord and Power adapter (non-sterile, reusable),
• Hysteroscope cable (non-sterile, reusable), and
• HDMI cable (non-sterile, reusable) (optional)

Both hysteroscopes are single-use and the rest of the components are reusable.

The image processor is powered by an AC adapter (100 – 240V AC, 50/60 Hz) or battery (7.4V DC).

The subject device includes 13 models of the ARMI Single-Use Hysteroscope. The models have a working length of 245 mm. The models have different image resolutions, tip angles, insertion diameters, and instrument channel diameters.

The subject devices are noted to contain two different LED models (0301, 9653) and three different image sensors (ovm6946/ochsa10/ov9734).

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The Unscented Menstrual Tampons are inserted into the vagina to absorb menstrual discharge.

The proposed unscented menstrual tampons are cylindrical devices designed to absorb menstrual blood during a women's period. They consist of a tampon, including an absorbent pledget ("absorbent core") completely surrounded by an overwrap ("security veil") and a removal string ("withdrawal cord"), and an applicator (except for the digital style). The tampon design is cylindrical, bullet-like shape. The applicator has a smooth, rounded tip for ease of insertion. According to different composition materials and design styles, the unscented menstrual tampons of this submission are divided into 3 categories (Unscented menstrual long applicator tampon, Unscented menstrual Cardboard Applicator Tampon, Unscented menstrual Digital Tampons) and 7 sub-categories (Cotton + cardboard tube, Organic cotton + cardboard tube, Cotton (digital style), Organic cotton(digital style), viscose (digital style), Cotton + plastic tube and Viscose + cardboard tube). For applicator-style tampons, they feature a built-in applicator made of plastic or cardboard that helps the users insert the tampons into the vagina by pushing the tampon out of the applicator. The digital style tampons consist of a plain tampon designed to be inserted manually using the fingers.

The tampons are provided in 4 absorbencies: Light(L) (≤6g), Regular(R) (6-9g), Super (S)(9-12g) and Super Plus (SP)(12-15g). For Cotton + cardboard tube and Organic cotton + cardboard tube, L and SP are applicable for this application. For Cotton (digital style), Organic cotton (digital style) and Viscose (digital style), only L is applicable. For Cotton + plastic tube and Viscose + cardboard tube, all those four absorbencies are applicable for this application.

Each device is individually wrapped and then packaged in sealed multi-unit containers for retail sale. All tampons and applicators are provided non-sterile and for single use only.

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Hybrid personal lubricant (water&silicone) is a personal lubricant for penile, anal and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

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FemVue® Controlled Saline-Air Device is intended to instill a consistent alternating pattern of saline and air as a continuous stream of contrast media into the uterus and fallopian tubes to be used in conjunction with an intrauterine catheter for performance of sono-hysterosalpingogram (Sono HSG).

The FemVue® Controlled Saline-Air Device is a sterile dual-barrel contrast media syringe that is connected to an intrauterine catheter to instill saline-air contrast medium as part of a sono-hysterosalpingogram (Sono-HSG) procedure. Ultrasound of the fallopian tubes can be performed with or without assessment of the uterine cavity.

The device operates by retraction of the plunger, which simultaneously fills the two syringes in the device with either air or saline. The device is then connected to a compatible uterine catheter and when the plunger is depressed, a consistent stream of saline and air is delivered into the uterus and fallopian tubes. The device is provided sterile via ethylene oxide (EO) sterilization and is intended for single-use.

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Ceryne Intimate Care is a silicone-based personal lubricant for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product is compatible with natural rubber latex, and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Ceryne Intimate Care is a non-sterile, silicone-based personal lubricant designed to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Its formulation consists of Dimethicone, Dimethiconol Silicone blend, 2-Octyldodecanol, Cholestrol, Span 60, Stearic Acid, Tocopheryl Acetate, Arlacel 165, Cetyl Stearyl Alcohol, Sodium Benzoate, Glycogen, L-Lactic Acid and Water. This device compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.

The lubricant is packaged in 15g and 30g tubes.

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