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Vita Vitro® Sperm Washing Medium is intended for preparation and washing of sperm for use in assisted reproduction procedures. Vita Vitro® Sperm Washing Medium is also intended for use in intrauterine insemination procedures. VitaVitro® Sperm Gradient Medium is intended for separation of motile sperm from seminal fluid for use in assisted reproduction procedures.

VitaVitro® Sperm Washing Medium and VitaVitro® Sperm Gradient Medium are ready-to-use solutions intended for preparing sperm for use in assisted reproductive procedures: - VitaVitro® Sperm Washing Medium is for sperm washing and for intrauterine insemination procedures. - VitaVitro® Sperm Gradient Medium is for sperm density-gradient centrifugation and separation from seminal fluid. Both devices have a similar base formulation; however, the VitaVitro® Sperm Gradient Medium formulation differs as it contains silane silica and does not contain Human Serum Albumin (HSA). The silane silica in the VitaVitro® Sperm Gradient Medium (upper layer 80%) generates the density gradient for sperm separation procedures. The subject devices are aseptically filtered, colorless solutions, contained in transparent and sterilized (gamma irradiation) polyethylene terephthalate glycol (PETG) bottles, sealed with high density polyethylene (HDPE) closures, provided in cardboard boxes, individually labeled and with an instruction for use provided as a package insert. The devices are provided in the following volumes: - VitaVitro® Sperm Washing Medium: 30mL, 60mL, and 125mL - VitaVitro® Sperm Gradient Medium: 12mL, 30mL, and 125mL Both devices have a two-year shelf-life when stored as recommended. These devices are for single-used only.

VitaVitro® Fertilization Medium is intended for preparation and handling of human gametes and for in vitro fertilization. VitaVitro® Gamete Buffer Medium is intended for human gamete and embryo short-term handling procedures outside the incubator, including washing and intracytoplasmic sperm injection (ICSI). VitaVitro® Flushing Buffer Medium is intended for use during ovarian follicle flushing and oocyte collection procedures for use in in vitro fertilization procedures.

This submission includes three media products: - . VitaVitro® Fertilization Medium is intended for preparation and handling of human gametes and for in vitro fertilization. Media provided in volumes of 30 ml and 60 ml. - . VitaVitro® Gamete Buffer Medium intended for human gamete and embryo short-term handling procedures outside the incubator, including washing and intracytoplasmic sperm injection (ICSI). Media provided in a single volume of 60 ml. - . VitaVitro® Flushing Buffer Medium intended for use during in vitro fertilization procedures for follicle flushing and oocyte collection. Media provided in volumes of 60 ml and 125 ml. All devices are aseptically filled into radiation-sterilized PETG bottles, are single-use only, and have a shelf-life of six-months when stored as recommended at 2-8°C.