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The Stork® OTC is indicated for over-the-counter home use by couples who have been unable to conceive naturally and who have received a diagnosis of low sperm count, sperm immobility or unfavorable vaginal environment. The Stork® OTC contains a cervical cap inside a condom-like silicone sheath. It is used to collect semen into a cervical cap then deliver it to the outside of the cervix as an aid to conception. The Stork® OTC should be used during the ovulatory phase of the menstrual cycle. The Stork® OTC Cervical Cap should not be left in place for longer than six hours.

The Stork® OTC package includes: one Instructions for Use, one Conceptacle® and one plastic applicator. Once the couple has decided to attempt to become pregnant, the Stork® OTC Conception System Instruction for Use recommends using the device during female's most fertile days in a given month. During sexual intercourse, semen will be collected using the Conceptacle®, a cervical cap that is pre-inserted into a condom-like sheath. The male removes the Conceptacle® from the penis by rolling it down and separating it from the penis. After removal, the rim of the cervical cap is lightly pinched so that the Condom-like Sheath can be separated. (The Cervical Cap and Condom-like Sheath are separated in two separate parts). The semen is contained in the cervical cap and its reservoir. The second component, the Applicator, is used for ease of transition of the Cervical Cap to the cervix. The applicator seals the Cervical Cap and contains the semen for transition through the vaginal tract, assisting the female in guiding the cap to the cervix and releasing the semen and the cap in front of the cervix. When the cervical cap is loaded onto the applicator (while it is still outside of the body), the Retainer locks onto the Cervical Cap and is delivered with the Cervical Cap intra-vaginally. The Retainer also has a removal cord that is attached for withdrawal. The Cervical Cap and Retainer then remain in place for up to 6 hours.

The Focus Touch Conception System is indicated for assisted insemination in instances where low sperm count, sperm immobility, or hostile vaginal environment has been diagnosed. The system (cervical cap in a condom-like silicone sheath) is used to collect semen into a cervical cap, and then deliver the cap to the outside of the cervix as an aid to conception. It is to be used at home following physician instruction. The Focus Touch Conception System should not be left in place for longer than 6 hours.

The Focus Touch™ Conception System includes detailed Instructions for Use, one Conceptacle and one plastic applicator. The system can be purchased packaged in a quantity of one (1) or three (3) individually packaged systems. Once the couple has decided to attempt to become pregnant, the Focus Touch™ Conception System Instruction for Use recommends using the device during female's most fertile days in a given month. During sexual intercourse, semen will be collected using the Conceptacle, a cervical cap that is pre-inserted into a condom-like sheath. The male removes the Conceptacle from the penis by rolling it down and separating it from the penis. After removal, the rim of the cervical cao is lightly pinched so that the Condom-like Sheath can be separated. (The Cervical Cap and Condom-like Sheath are separated in two separate parts). The semen is contained in the cervical cap and its reservoir. The second component, the Applicator, is used for ease of transition of the Cervical Cap to the cervix. The applicator seals the Cervical Cap and contains the semen for transition through the vaginal tract, assisting the female in guiding the cap to the cervix and releasing the semen and the cap in front of the cervical cap is loaded onto the applicator (while it is still outside of the Retainer locks onto the Cervical Cap and is delivered with the Cervical Cap intravaginally. The Retainer also has a removal cord that is attached for withdrawal. The Cervical Cap and Retainer then remain in place for up to 6 hours.

The Sagami Polyurethane Semen Collection Device is intended to be used as an accessory to the Oves Cervical Cap to collect semen for transfer to the cap prior to insertion in artificial insemination procedures.

The subject device is a polyurethane condom.

The Conceivex Conception Kit is indicated for assisted insemination in situations in which low sperm count, sperm immobility, or hostile vaginal environment have been diagnosed. The kit is used for semen collection and placement into the bowl of a cervical cap as an aid to conception. It is to be used at home following physician instruction. The Cap should not be left in place for longer than 6 hours.

The Conceivex Conception Kit includes the following literature: Instructions for Use, a "Conception Wheel" to help plan in timing a pregnancy, a "Conception Journal" booklet to assist in charting the fertility cycle and keep track of medical information, and a Medical Provider Note to alert the woman's health care provider that she is trying to become pregnant. The kit contains three identical boxes, each of which contain: one Oves Cervical Cap, one cervical cap for practice, one Avanti Semen Collection Condom, eight Ovulation Predictors, a Pregnancy Test, and a sample of 'Pre Vaginal Lubricant. The three boxes enable the woman to try to conceive by using the Kit through three ovulation cycles. Once the couple has visited with a physician and decides they would like to become pregnant, they begin recording details of their cycle in the Conception Journal. Next, using the ovulation predictor, they identify their most fertile day in a given month. During sex they use the semen collector and afterwards transfer the specimen into the Conception Cap. The Conception Cap is then placed over the cervix for 4-6 hours. At the end of the woman's cycle, she uses the Conceivex pregnancy test kit to determine if conception has been achieved.