Search Results

The Rhea Cup is a receptacle placed in the vagina to collect blood and cellular debris that is extruded from the uterus via the cervix during menstruation.

The Rhea Cup is a reusable menstrual cup placed in the vagina to collect blood and cervical debris that is extruded from the uterus via the cervix during menstruation. The Rhea Cup will be made in two model sizes to allow for the variability of the female vagina and menstrual flow due to normal differences between women as well as the effects of childbirth. Model 1 holds approximately 25ml of fluid and is for women who have never given birth vaginally. Model 2 holds approximately 30ml of fluid and is for women who have given birth vaginally. The Rhea Cup is made of a flexible silicone elastomer which allows for easy insertion and a comfortable fit in the body. This material is durable and allows the cup to be used during many menstrual cycles. The Rhea Cup is comprised of a body, which acts as a receptacle for fluid and a ribbed tail attached at the base of the body, providing support when removing the cup from the vagina. The Rhea Cup is made of a silicone elastomer, which has been cleared by the FDA for use in the BelleCup (K092985) predicate device.

The Solace Infusion System is intended for continuous infusion of medications directly into the intraoperative site for post-operative pain management. Additional routes of administration include subcutaneous and intramuscular infusion.

Apex's Solace Post-Operative Pain Relief Infusion System is a single use infusion device, which incorporates an elastomeric bladder with a permanently attached fixed flow rate administration set designed to deliver medication at a constant flow rate. The medication enters the body via a catheter, which is inserted near a surgical wound site then positioned under the skin. The pump attaches to the catheter at the distal end of the administration set. The catheter consists of four design options (same as predicate devices).