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CE Marked (CE 0086)
DMV5-005, 1 kit (5 ml) |
| Indications for Use |
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For vitrification (ultra-rapid freezing) and cryostorage of human blastocysts. |
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| Storage and Shelf Life |
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Store at 2-8°C and protected from light. One (1) year from the date of manufacture. |
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| Disposal Consideration |
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Treat or dispose of waste material in accordance with all local state/provincial, and national requirements. Dispose with laboratory waste. |
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| Composition |
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1 X 5 ml vial of DMSO Equilibration Solution (blue cap)
1 X 5 ml vials of Vitrification Solution (white cap)
10 X embryo GPS® dishes
Base Components
Sodium Chloride, Potassium Chloride, Calcium Chloride, Sodium Bicarbonate, Glucose, Lactate Na Salt, Amino Acids, Phenol Red, HEPES, Gentamicin Sulfate* (10 μg/ml)
| Equilibration Solution |
Vitrification Solution |
| Dimethyl Sulfoxide (7.5% v/v) |
Dimethyl Sulfoxide (15% v/v) |
| Ethylene Glycol (7.5% v/v) |
Ethylene Glycol (15% v/v) |
| Human Serum Albumin* (10 mg/ml) |
Sucrose (0.5 M) |
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Human Serum Albumin* (10 mg/ml) |
*from therapeutic-grade source material |
| Instructions for Use |
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| Quality Control Specifications |
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| The solutions in the global® DMSO Blastocyst Vitrification Kit are membrane filtered and aseptically processed according to cGMP procedures which have been validated to meet a sterility assurance level (SAL) of 10-3. |
| Assay (performed for each batch) |
Specification |
| pH — Equilibration and Vitrification Solutions |
7.1-7.5 |
| Osmolality — Equilibration Solution |
2600-3500 mOsM |
| Osmolality — Vitrification solution |
4900-6600 mOsM |
| Endotoxin (LAL) - Equilibration and Vitrification Solutions |
< 1.0 EU/ml |
| Sterility Test (bacterial and fungal screen, SAL 10–3) |
PASS |
| 1-cell Mouse Embryo Assay (% expanded blastocysts at 96 h of culture following step-in, step-out of vitrification and warming solutions) |
> 80% |
| embryo GPS® Dishes |
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| Endotoxin (LAL) |
< 20 EU/device |
| 1-cell Mouse Embryo Assay (% expanded blastocysts after 96 h) |
> 80% |
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| Precautions and Warnings |
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- Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician (or properly licensed practitioner).
- Caution: 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 for vitrification of human blastocysts.
- Warning: The long term safety of blastocyst vitrification on children born from this procedure is unknown.
- Warning: The safety and effectiveness of vitrification has not been fully evaluated in human embryos that have not yet reached the blastocyst stage of development.
- Not to be used for injection.
- Do not resterilize.
- 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
- 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.
Contains:Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens. There are no reports of virus transmissions with albumin manufactured to European Pharmacopoeia specifications by established processes. It is strongly recommended that every time that global® DMSO Blastocyst Vitrification Kit is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
- global® DMSO Blastocyst Vitrification Kit contains the antibiotic gentamicin sulfate. Appropriate precautions should be taken to ensure that the patient is not sensitized to this antibiotic.
- To avoid problems with contamination, practice aseptic techniques.
- Use a legally marketed carrier and storage device appropriate for blastocyst vitrification procedures.
- 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.
- The rate of cooling in the carrier and storage device should be between 1,800 to 20,000°C/min. (Camus et al., 2006)
- The global® DMSO Blastocyst Vitrification Kit is intended for single use only (the vitrification of blastocysts) from one patient on one day). Discard any unused product after opening.
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Link to global® DMSO Blastocyst Vitrification Kit IFU