FertiVit Cooling/Warming

FertiVit^TM Cooling / FertiVit^TM Warming

Intended use:
FertiVit™ Cooling / FertiVit™ Warming are a set of media for vitrification and warming of human oocytes and embryos
(zygote till blastocyst).

FertiVit™ Cooling/FertiVit™ Warming are Ready to use.

Composition
FertiVit™ Cooling / FertiVit™ Warming are HTF-based and contain HEPES and human serum albumin (11-20 g/l depending on the individual medium, medicinal substance derived from human blood and sucrose plasma). None of the media contain antibiotics. FertiVit™ Cooling media have increasing concentrations of DMSO and ethylene glycol (EG). FertiVit™ Cooling 5 also contains Ficoll. FertiVit™ Warming media have decreasing concentrations of sucrose.

Further information on the composition of the medium can be found in the material safety data sheet.

Regulatory

Europe: (CE-marked MDR, Notified Body number 2797)
Brazil: registred
Other regions: Information available upon request

Product order codes
FVC_KIT: FertiVit™ Cooling kit
FVW_KIT: FertiVit™ Warming kit

Product specifications

pH	7.2-7.5 (release criteria: 7.2-7.4)
Osmolality	Pre-incubation medium / Warming 6: 270-295mOsm/kg (release criteria: 270-290mOsm/kg) Warming 3: 805-865mOsm/kg (release criteria: 805-850) Warming medium 4: 535-565mOsm/kg Warming medium 5: 405-435mOsm/kg
Sterility test by the current Ph. Eur. 2.6.1/ USP <71>	No growth
Endotoxin	< 0.25 EU/mL
Mouse embryo assay (% blastocysts after 96 hours, after sequential exposure to cooling and warming media)	≥ 80%
Shelf life	12 months from date of production

Frequently Asked Questions Certificate Of Analysis

Cryopreservation

FertiVit^TM Cooling and FertiVit^TM Warming are sets of cell culture media designed for the vitrification and warming of human oocytes up tot blastocyst stage human embryos

Instructions For Use

Summary of safety and clinical performance

SSCP

FertiVitTM Cooling / FertiVitTM Warming

FertiVitTM Cooling and FertiVitTM Warming are sets of cell culture media designed for the vitrification and warming of human oocytes up tot blastocyst stage human embryos

Instructions For Use

Summary of safety and clinical performance

Material Safety Data Sheet

FertiVit^TM Cooling / FertiVit^TM Warming

FertiVit^TM Cooling and FertiVit^TM Warming are sets of cell culture media designed for the vitrification and warming of human oocytes up tot blastocyst stage human embryos