Address:level2, 321 Kent Street,Sydney New South Wales,AU
Device Description : The Geri Embryo Incubator is a benchtop incubator with six modular incubation ch The Geri Embryo Incubator is a benchtop incubator with six modular incubation chambers each with its own temperature control capability and separate gas inlet feed. Each chamber contains heating elements in its lid and base, together with an orange light source (591 nm) and camera with integrated optics thattake time-lapse images of embryos and allows operators to view embryos without removing them from the incubation chamber. Inside each chamber is a filter used to filter the gas mixture entering the incubation chamber from the gas supply. The gas is supplied from standard premixed medical gas cylinders.The Geri Embryo Incubator includes firmware to control the incubator settings, and software to control patient information and settings.
Device Class : 1
Duns Number: 752103403
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Geri Dish is intended to be used for preparation, storage and imaging of hum The Geri Dish is intended to be used for preparation, storage and imaging of human embryos. The Geri Dish is intended to be used only with the Geri Embryo Incubator.
Device Class : 2
Duns Number: 752103403
Premarket Exempt : No
Prescription Use : Yes
Device Description : Geri Connect & Geri Assess connects one or more Geri incubators through a LAN. T Geri Connect & Geri Assess connects one or more Geri incubators through a LAN. The Geri Connect & Geri Assess software enables multiple users to access and review patient/embryo data, using a Chrome browser on their PC workstations.
Device Class : 1
Duns Number: 752103403
Premarket Exempt : No
Prescription Use : No
Device Description : The Geri Water Bottle is a two-piece (base and top) item, manufactured by inject The Geri Water Bottle is a two-piece (base and top) item, manufactured by injection molding in polystyrene material.
Device Class :
Duns Number: 752103403
Premarket Exempt : No
Prescription Use : Yes
Device Description : Geri Connect & Geri Assess connects one or more Geri incubators through a LAN. T Geri Connect & Geri Assess connects one or more Geri incubators through a LAN. The Geri Connect & Geri Assess software enables multiple users to access and review patient/embryo data, using a Chrome browser on their PC workstations.
Device Class : 1
Duns Number: 752103403
Premarket Exempt : No
Prescription Use : No
Device Description : Geri Connect & Geri Assess connects one or more Geri incubators through a LAN. T Geri Connect & Geri Assess connects one or more Geri incubators through a LAN. The Geri Connect & Geri Assess software enables multiple users to access and review patient/embryo data, using a Chrome browser on their PC workstations.
Device Class : 1
Duns Number: 752103403
Premarket Exempt : No
Prescription Use : No
Device Description : The Gems Oocyte Retrieval Buffer is an assisted reproduction medium used for rem The Gems Oocyte Retrieval Buffer is an assisted reproduction medium used for removal of oocytes from ovarian follicles. It consists of salts, energy substrates, amino acids buffering agents, stabilizers and antibiotics. This device has direct contact with the patients and oocytes. This product is a single-use device that is aseptically filled into sterilized bottles and has a sterility assurance level (SAL) of 10^-3. It is tested for pH, osmolality, embryotoxicity, endotoxin and sterility before lot release and has a shelf-life of 30 weeks.
Device Class : 2
Duns Number: 752103403
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Gems Oocyte Retrieval Buffer is an assisted reproduction medium used for rem The Gems Oocyte Retrieval Buffer is an assisted reproduction medium used for removal of oocytes from ovarian follicles. It consists of salts, energy substrates, amino acids buffering agents, stabilizers and antibiotics. This device has direct contact with the patients and oocytes. This product is a single-use device that is aseptically filled into sterilized bottles and has a sterility assurance level (SAL) of 10^-3. It is tested for pH, osmolality, embryotoxicity, endotoxin and sterility before lot release and has a shelf-life of 30 weeks.
Device Class : 2
Duns Number: 752103403
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Gems Fertilisation Medium is intended for in vitro fertilization and transfe The Gems Fertilisation Medium is intended for in vitro fertilization and transfer of embryos to theuterus.
Device Class : 2
Duns Number: 752103403
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Gems Cleavage Medium is intended for culture of embryos from fertilization t The Gems Cleavage Medium is intended for culture of embryos from fertilization to cleavage stageand transfer of embryos to the uterus.
Device Class : 2
Duns Number: 752103403
Premarket Exempt : No
Prescription Use : Yes