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CE Marked (CE 0086)

LGGG-020, 20 ml
LGGG-050, 50 ml
LGGG-100, 100 ml
LGGG-250, 250 ml

Indications for Use   Culture of human embryos from zygote to blastocyst, embryo transfer.
Storage and Shelf Life   Store at 2-8°C and protected from light. Ten (10) weeks from the date of manufacture.
Composition   A bicarbonate-buffered medium replete with glucose, lactate, pyruvate and all 20 amino acids is optimal to support the growth and development of human embryos in vitro.

Sodium Chloride, Potassium Chloride, Sodium Pyruvate, Calcium Chloride, Potassium Phosphate, Magnesium Sulfate, Sodium Bicarbonate, Glucose, Sodium Lactate, Amino Acids, EDTA, Phenol Red, Gentamicin Sulfate* (10 μg/ml) *from therapeutic-grade source material
Instructions for Use  

Link to global® IFU

Quality Control Specifications  
Assay (performed for each batch) Specification
pH (with 5% CO2) 7.2-7.4
Osmolality 260-270 mOsM
Endotoxin (LAL) < 0.5 EU/ml
Sterility Test (bacterial and fungal screen, SAL 10–3) PASS
1-cell Mouse Embryo Assay (% expanded blastocysts at 96 h of culture) > 80%

Precautions and Warnings
  1. Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician (or properly licensed practitioner).
  2. Caution: The user should read and understand the Instructions for Use, Precautions and Warnings, and be trained in the correct procedure before using global® for human embryo culture or transfer.
  3. Not to be used for injection.
  4. Devices are not intended for resterilization.
  5. 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
  6. global® contains the antibiotic gentamicin sulfate. Appropriate precautions should be taken to ensure that the patient is not sensitized to this antibiotic.
  7. To avoid problems with contamination, practice aseptic techniques
  8. Discard unused medium within 7 days of opening. Do not use after expiry date.