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cryo-GO Vitrification Device is a cryopreservation device intended for use in vitrification procedures to contain and maintain human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

The cryo-GO Vitrification Device is a sterile, single-use, closed assisted reproduction storage device for use in vitrification procedures to contain and maintain oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. The cryo-GO Vitrification Device is composed of an injection molded body with an extended loading tip (4.45 inches long with a 0.65 inch loading tip), an injection molded cap (1.76 inches), and a total device combined length of 5.05 inches. Visible marks are on the distal loading tip, body, and at the opening of the cap, to indicate the location of the tip, the upright orientation of the device and the opening of the cap, respectively. The body and cap include a taper design that create a seal when assembled prior to plunging the device in liquid nitrogen for vitrification and for subsequent storage. The device is provided in five different colors: red, yellow, green, blue, and purple. The subject devices are radiation sterilized to a sterilization assurance level of 10-6 and have a one-year shelflife.

SSS-NX is intended for use in assisted reproductive technology (ART) procedures which include gamete and embryo manipulation and culture. These procedures include the use of SSS-NX as a supplement for ART media.

SSS-NX (Serum Substitute Supplement-NX) is an assisted reproduction media supplement consisting of a combination of human serum proteins (approximate protein content 50 mg/mL, 5% w/v) in a saline solution. Of this, ≥83% is albumin and ≤17% is globulins. The product is supplied as a ready to use liquid in 10 mL containers distributed in a twelve (12) x 10 mL kit and a 100 mL liquid packaged in a 125 mL container.

PRIME-XV FreezIS DMSO-Free MD is for use in human ex vivo tissue and cell culture processing applications.

PRIME-XV Freez/S DMSO-Free MD is a liquid medium intended for use in human ex vivo tissue and cell culture processing applications. It is a chemically defined cryogenic preservation solution for human cells for use in a professional Healthcare Facility that performs cell culture and cell handling. It has comparable post-thaw cell viability as solutions containing dimethyl sulfoxide (DMSO), maintains potency of stem cells throughout cryopreservation, eliminates the risk of DMSO in stem cell therapy applications, is animal componentfree, enables cell preservation at -80°C to -196°C environments and is manufactured under cGMP conditions.

Vit Kit - Freeze NX (Vitrification Freeze Kit) is intended for use in the vitrification of oocytes (MI) and pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. Vit Kit - Warm NX (Vitrification Warm Kit) is intended for use in the thawing of vitrified occytes (MII) and pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

The five media products that comprise the two kits, Vit Kit - Freeze NX and Vit Kit -Warm NX, consist of a basal media of Continuous Single Culture Medium (CSCM) which utilizes MOPS, HEPES and sodium bicarbonate buffers, 20% (v/v) DSS, 10μg/mL gentamicin and varying levels of cryoprotectants, including dimethyl sulfoxide (DMSO), trehalose, and ethylene glycol (EG). The two freeze media in the Vit Kit – Freeze NX are intended to be used sequentially for the preparation and cryopreservation of oocytes (MII) and pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. The three media in the Vit Kit - Warm NX are intended for sequential use in the thawing and recovery of cryopreserved oocytes (MII) and pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

Arctic™ Sperm Cryopreservation Medium is intended for use in assisted reproductive procedures involving the cryopreservation and storage of human sperm.

The Arctic™ Sperm Cryopreservation Medium is a modified version of the predicate device (K991337). It is a defined medium consisting of salts, buffering materials, cryoprotectants, vitamins, amino acids, minerals, carbohydrates, surfactant, energy source, and human serum albumin. The Arctic™ Sperm Cryopreservation Medium is a single-use device that is aseptically filled into sterilized vials and has a sterility assurance level (SAL) of 10-3. This medium is supplied in a fill volume of 5 mL. and twelve (12) 5mL vials are included in a package, The product is tested for pH, osmolality, sperm cyrosurvival, endotoxin and sterility before lot release, and has a shelf-life of 18 months.

The Continuous Single Culture®-NX (CSCM-NX) is intended for use as a culture medium for human gametes and embryos from fertilization through day 5/6 of development in vitro.

The Continuous Single Culture®-NX (CSCM-NX) is a culture medium using a formulation modified from the predicate device. It is intended for culture of embryos from fertilization to blastulation. This medium consists of salts, energy substrates, amino acids, buffering agents, nutrients supplements, and antibiotics. This product is a single-use device supplied in a fill volume of 20 mL and 60 mL. It is aseptically filled into sterilized bottles and has a sterility assurance level (SAL) of 10⁻⁶. The product is tested for pH, osmolality, embryotoxicity, spermtoxicity, endotoxin, and sterility before lot release. The product has a four-month shelf-life and remains stable for four weeks after opening/closing of the bottle when it is stored at 2-8°C.

The Continuous Single Culture®-NX Complete (CSCM-NXC) is intended for use as a culture medium for human gametes and embryos from fertilization through day 5/6 of development in vitro. This device can be used for transfer of embryos to the uterus.

The Continuous Single Culture®-NX Complete (CSCM-NXC) is a culture medium using a formulation modified from the predicate device. It is intended for culture of embryos from fertilization to balstulation and transfer of embryos to the uterus. This medium consists of salts, energy substrates, amino acids, buffering agents, nutrients supplements, antibiotics, and human serum albumin. This product is a single-use device supplied in a fill volume of 20 mL. It is aseptically filled into the sterilized bottle and has a sterility assurance level (SAL) of 10-3. The product is tested for pH, osmolality, embryotoxicity, spermtoxicity, endotoxin, and sterility before lot release. The product has a four-month shelf-life and remains stable for four weeks after open/close of bottle, when it is stored at 2-8°C.

Vit Kit® - Freeze (Vitrification Freeze Kit) is intended for use in the vitrification of oocytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. Vit Kit® - Thaw (Vitrification Thaw Kit) is intended for use in the thawing of vitrified oocytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

The five media that comprise the two kits, Vit Kit® - Freeze and the Vit Kit® - Thaw are all based upon a modified formulation of Medium 199 is HEPES buffered and contains 20% (v/v) dextran substitute supplement (DSS), 35μ.g/mL gentamicin and varying concentrations of dimethyl sulfoxide (DMSO), ethylene glycol (EG), and sucrose. The two freeze media in the Vit Kit® - Freeze are intended to be used sequentially, for the preparation and cryopreservation of PN, day 3 cleavage stage, and blastocyst stage embryos and oocytes. The three thaw media in the Vit Kit®- Thaw are intended for sequential use in the thawing and recovery of cryopreserved human PN, cleavage stage, and blastocyst embryos and oocytes.

Continuous Single Culture™ Complete is intended for use as a culture medium for human gametes and embryos from fertilization through day 5/6 of development in vitro.

The Continuous Single Culture™ Complete is based upon the Single Step Medium™ (K072609) formulation that is supplemented with Human Serum Albumin, H.S.A. The Continuous Single Culture™ Complete is composed of a balanced mixture of salts, amino acids and other nutrients that have been shown to support embryo development. The Continuous Single Culture™ Complete is designed to be used as a culture media for fertilization and for development of embryos until the desired developmental stage (up to 5/6 days). Selected embryos are then moved to an embryo transfer media prior to transfer to the uterus. The Continuous Single Culture™ Complete is supplied in liquid form, and contains gentamicin sulfate as a preservative and a therapeutic grade of Human Serum Albumin (K983584). Liquid Continuous Single Culture™ Complete is supplied in a fill volume of 20 mL. Continuous Single Culture™ Complete has utility as a culture medium from fertilization through day 5/6 of development. The fertilized oocyte (zygote) is allowed to grow in the culture dish, supported by a culture medium and an appropriate protein supplement, in a carbon dioxide incubator at 37°C until the desired stage of development is achieved. Selected embryos are then moved to an embryo transfer media prior to transfer to the uterus. Continuous Single Culture™ Complete is supplied as a ready to use liquid in 20 mL bottles.

Multipurpose Handling Medium™ (MHM™) is intended for use in assisted reproductive procedures which involve the manipulation of gametes or embryos. Specifically, Multipurpose Handling Medium™) is indicated for use as an oocyte retrieval medium during ovarian follicle aspiration procedures (not for flushing ovarian follicles), washing sperm prior to IVF and ICSI fertilization procedures, and for transport of the embryo to the uterus during embryo transfer procedures.

The Multipurpose Handling Medium™ (MHM™) is based upon the mHTF (K983586) formulation. The formula for the Multipurpose Handling Medium™ (MHM™) is based upon the composition of modified HTF, K983586. The medium uses a buffering system composed of HEPES (N-2-Hydroxyethylpiperazine-N1 - - 2 - - ethanesulfonic acid). MOPS . (3 Morpholinopropane - 1- sulfonic acid) and Sodium Bicarbonate. This buffering system provides pH maintenance over the physiologic range and does not require the use of a CO2 Incubator. - The product also contains 10 ug/mL gentamicin. Multipurpose Handling Medium™ (MHM™) has utility as an oocyte retrieval medium, in procedures that aspirate oocytes from the patient's ovarian follicles. Multipurpose Handling Medium™ (MHM™) is used only in the oocyte collection vessel and is not for use in flushing oocytes from ovarian follicles. Once the oocyte has been retrieved, it is placed into a culture dish with an appropriate amount of a culture medium (does not include MHM™), as specified by the user's internal procedures, and fertilization is allowed to occur. Multipurpose Handling Medium™ (MHM™) can also be used to wash sperm in preparation for fertilization by conventional IVF or ICSI procedures. The fertilized oocyte (zygote) is allowed to grow in the culture dish, supported by a culture medium (does not include MHM™), as specified by the user's internal procedures, and an appropriate protein supplement, in a carbon dioxide incubator at 37°C until the desired stage of development is achieved. The embryo is removed from the culture dish, placed into an appropriate amount of Multipurpose Handling Medium™ (MHM™) for transfer into the uterus. Multipurpose Handling Medium™ (MHM™) is supplied as a ready to use liquid, in 100 and 500 mL bottles.