FDA.reportPublic FDA data

Geri Software Connect and Assess 1.3

Primary DI
09348265003079
Brand
Geri Software Connect and Assess 1.3
Company
GENEA BIOMEDX PTY LTD
Model
GERI-SCA-04
Device description
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.
Published
2018-06-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K180188000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180188000Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri DishGenea Biomedx Pty, Ltd.2018-06-07MQG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348265003079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348265003079093482650030799348265003079

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction embryo-assessment softwareAn application software program intended to analyse image data captured by an embryo-assessment microscope camera system to store, and allow comparison/evaluation of, acquired embryo images, to assist embryo selection during assisted reproduction/in vitro fertilization (IVF). Typically it allows the user to store relevant patient medical records, analyse still images and videos of embryonic growth, annotate or categorize images, and may provide decision support. It is intended to be used by healthcare professionals in a clinical setting.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
752103403
Device count
1
Serial number
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
09348265003086Geri Software Connect and Assess 2.0GERI-SCA-052018-06-19
09348265003000Geri Embryo IncubatorGERI-INS-012017-12-08
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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Primary DI, Brand, Company table
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06909262200279ZEISS Primostar 3Carl Zeiss Suzhou Co., Ltd.MTX2026-07-23
06909262200309ZEISS Primostar 3Carl Zeiss Suzhou Co., Ltd.MTX2026-07-23
06909262200347ZEISS Primostar 3Carl Zeiss Suzhou Co., Ltd.MTX2026-07-23
06909262200354ZEISS Primostar 3Carl Zeiss Suzhou Co., Ltd.MTX2026-07-23
06909262200385ZEISS AxiolabCarl Zeiss Suzhou Co., Ltd.MTX2026-07-23
06909262200613Zeiss Primostar 1Carl Zeiss Suzhou Co., Ltd.MTX2026-07-23
06909262200620ZEISS Primostar 1Carl Zeiss Suzhou Co., Ltd.MTX2026-07-23
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