global® Collect™

CE Marked (CE 0086)
GCOL-100, 100 ml
GCOL-500, 500 ml

Indications for Use

Oocyte retrieval and washing.

Storage and Shelf Life

Store at 2-8°C and protected from light. Ten (10) weeks from the date of manufacture. For best results, use within four (4) weeks.

Composition

Sodium Chloride; Potassium Chloride; Calcium Chloride; Potassium Phosphate; Magnesium Sulfate; Sodium Bicarbonate; Glucose; Lactate Na Salt; Sodium Pyruvate; Amino Acids; EDTA; Phenol Red; HEPES; Gentamicin Sulfate (10 μg/ml)

Quality Control Specifications
Physiochemical Tests Specification
pH at room temperature 7.35 — 7.45
pH at 37°C 7.2 — 7.3
Osmolality 260 — 270
Biological Tests Specification
Lal Endotoxin < 0.50 EU/ml
Sterility Test, membrane filtration Negative
1-cell Mouse Embryo Assay (% blastocysts at 96h of culture) > 80%
Precautions and Warnings
  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. global® Collect® contains the antibiotic gentamicin sulfate. Appropriate precautions should be taken to ensure that the patient is not sensitized to this antibiotic.
  4. global® Collect® must be used at 37°C. The pH of global® Collect® is balanced for use at 37°C.
  5. global® Collect® contains only a low concentration of sodium bicarbonate and should not be gassed, or used for culture under CO2.
  6. 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
  7. To avoid problems with contamination, practice aseptic techniques and discard minimal amounts of excess medium remaining in the bottle.
  8. Once the bottle is opened, store the product tightly capped at 2-8ºC and protected from light.
  9. The user should read and understand the Instructions for Use, Precautions and Warnings, and be trained in the correct procedure before using global® Collect® for oocyte retrieval and washing.