Geri Embryo Incubator

Primary DI
09348265003000
Brand
Geri Embryo Incubator
Company
GENEA BIOMEDX PTY LTD
Model
GERI-INS-01
Device description
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.
Published
2017-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MQGAccessory, Assisted Reproduction
MQKLabware, Assisted Reproduction
MTXMicroscope And Microscope Accessories,Reproduction,Assisted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQGAccessory, Assisted ReproductionObstetrics/Gynecology2
MQKLabware, Assisted ReproductionObstetrics/Gynecology2
MTXMicroscope And Microscope Accessories, Reproduction, AssistedObstetrics/Gynecology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171736000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171736000Geri Embryo Incubator and Geri DishGenea Biomedx Pty, Ltd.2017-11-15MQG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348265003000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348265003000093482650030009348265003000

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction heater/incubatorAn electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls.

Regulatory Flags#

DUNS number
752103403
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09348265003017Geri DishGERI-DSH-202017-12-08
09348265003048Geri Water BottleGERI-WAT-012018-05-04
29348265003011Geri DishGERI-DSH-202017-12-08
09348265003024Geri Connect Server (including software)GERI-GCS-012018-06-19
09348265003079Geri Software Connect and Assess 1.3GERI-SCA-042018-06-19
09348265003086Geri Software Connect and Assess 2.0GERI-SCA-052018-06-19
09348265004007Oocyte Retrieval Buffer ORB-502017-10-25
09348265004076Oocyte Retrieval BufferORB-202017-10-25
09348265005004Gems Fertilisation MediumFEM-502017-05-23
09348265005011Gems Cleavage MediumCLM-502017-05-22
09348265005028Gems Blastocyst MediumBLM-502017-05-23
09348265005035Gems Geri MediumONE-502017-05-23
09348265005042Gems Fertilisation MediumFEM-202017-12-11
09348265005059Gems Cleavage MediumCLM-202017-12-11
09348265005066Gems Blastocyst MediumBLM-202017-12-11
09348265005073Gems Geri MediumONE-202017-12-11
09348265006032Gems Vitrification SetVIT-012017-06-23
09348265006070Gems Warming SetWRM-012017-06-23
09348265007008Gems VitBaseVBS-202017-05-23

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