global® DMSO Blastocyst Vitrification Kit

For vitrificaton of human blastocysts.
DMV5-005, 1 kit (5 ml)

For vitrification (ultra-rapid freezing) and cryostorage of human blastocysts.

This kit is intended to be used in conjunction with the global® DMSO Blastocyst Vitrification Warming Kit

1 X 5 ml vial of DMSO Equilibration Solution (blue caps)
1 X 5 ml vials of Vitrification Solution (white caps)
10 X embryo GPS® dishes

Base Components

Sodium Chloride; Potassium Chloride; Calcium Chloride; Potassium Phosphate; Magnesium Sulfate; Sodium Bicarbonate; Glucose; Lactate Na Salt; Sodium Pyruvate; Amino Acids; EDTA; Phenol Red; Gentamicin; HEPES

Equilibration Solution Base Components

Dimethyl Sulfoxide (7.5% v/v)
Ethylene Glycol (7.5% v/v)
Human Serum Albumin (10 mg/ml)

Vitrification Solution Base Components

Dimethyl Sulfoxide (15% v/v)
Ethylene Glycol (15% v/v)
Sucrose (0.5 M)
Human Serum Albumin (10 mg/ml)

Store at 2-8°C and protected from light.

1 year from the date of manufacture when stored unopened at 2-8°C and protected from light.

The solutions in the global® DMSO Vitrification Kit are membrane filtered and aseptically processed according to cGMP procedures which have been validated to meet a sterility assurance level (SAL) of 0.001.

1. Not to be used for injection.
2. Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician (or properly licensed practitioner).
3. This product contains human serum albumin, a derivative of human blood. The human serum albumin used in the preparation of this product has been heated at 60°C for ten hours.
   Caution: All blood products should be treated as potentially infectious. Source material from which this product was derived was found negative when tested for antibodies to HIV, HBc, HCV, and HTLV I/II and non-reactive for HbsAg, HCV RNA and HIV-1 RNA and syphilis. No known test methods can offer assurances that products derived from human blood will not transmit infectious agents.
4. Warning: The long term safety of blastocyst vitrification on children born from this procedure is unknown.
5. Caution: The safety and effectiveness of vitrification has not been fully evaluated in human embryos that have not yet reached the blastocyst stage of development.
6. global® DMSO Blastocyst Vitrification Kit solutions contain the antibiotic gentamicin sulfate. Appropriate precautions should be taken to ensure that the patient is not sensitized to this antibiotic.
7. Do not use the product if:
   • the product packaging appears damaged or if the seal is broken
   • the expiry date has been exceeded
   • the product becomes discolored, cloudy, or shows evidence of particulate matter
8. To avoid problems with contamination, practice aseptic techniques and discard minimal amounts of excess medium remaining in the bottle.
9. Once the bottle is opened, store the product tightly capped at 2-8ºC and protected from light.
10. The user should read and understand the Instructions for Use, Precautions and Warnings, and be trained in the correct procedure before using global® DMSO Blastocyst Vitrification Kit.
11. Use a legally marketed carrier and storage device appropriate for blastocyst vitrification procedures.
12. Use a closed storage system to prevent the potential risk of viral contamination and do not use open storage systems where the sample comes in direct contact with liquid nitrogen.
13. The global® DMSO Blastocyst Vitrification Kit is intended for single use only (the cryopreservation of the blastocysts from one patient on one day). Discard any unused product after opening.