FDA.report

Geri Software Connect and Assess 1.3

Primary DI
09348265003079
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
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Regulatory Flags

DUNS number
752103403
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
09348265003079PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
09348265003079PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
MQKLabware, Assisted Reproduction2Obstetrics/Gynecology884.6160NEligible

Premarket Submissions

SubmissionSupplement
K180188000

Premarket Details

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

GMDN Terms

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.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

No records found.

Other Devices From This Company

Primary DIBrandModelCatalogPublished
29348265003011Geri DishGERI-DSH-202017-12-08
09348265003048Geri Water BottleGERI-WAT-012018-05-04
09348265003024Geri Connect Server (including software)GERI-GCS-012018-06-19
09348265003086Geri Software Connect and Assess 2.0GERI-SCA-052018-06-19

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