Washing mHTF w/ HEPES & Phenol Red

Washing mHTF w/ HEPES & Phenol Red  
shopping cart to washing HTF w/ HEPES & Phenol red
CE Marked (CE 0086)

LGFR-100, 100 ml
LGFR-500, 500 ml

Indications for Use   For human oocyte retrieval and washing outside of a CO2 incubator.
Storage and Shelf Life   Store at 2-8°C and protected from light. Fourteen (14) weeks from the date of manufacture.
Composition   A HEPES-buffered medium is required when gametes and embryos are handled outside of a CO2 incubator.

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

Link to Washing mHTF w/ HEPES & Phenol Red IFU

Quality Control Specifications  
Assay (performed for each batch) Specification
pH 7.2-7.4
Osmolality 280-292 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: Caution:The user should read and understand the Instructions for Use, Precautions and Warnings, and be trained in the correct procedure before using the Washing mHTF w/ HEPES & Phenol Red when handling gametes and embryos outside a CO2 incubator.
  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. Washing mHTF w/ HEPES & Phenol Red contains the antibiotic gentamicin sulfate. Appropriate precautions should be taken to ensure that the patient is not sensitized to this antibiotic.
  7. Washing mHTF w/ HEPES & Phenol Red contains only a low concentration of sodium bicarbonate and should not be gassed, or used for culture under CO2.
  8. To avoid problems with contamination, practice aseptic techniques and discard minimal amounts of excess medium remaining in the bottle.
  9. Discard unused medium within 7 days of opening.