Geri Software Connect and Assess 2.0

GUDID 09348265003086

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.

GENEA BIOMEDX PTY LTD

Assisted reproduction embryo-assessment software
Primary Device ID09348265003086
NIH Device Record Key35a073df-e1e6-4cea-8a7a-8a3613f9eec2
Commercial Distribution StatusIn Commercial Distribution
Brand NameGeri Software Connect and Assess 2.0
Version Model NumberGERI-SCA-05
Company DUNS752103403
Company NameGENEA BIOMEDX PTY LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109348265003086 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQGAccessory, Assisted Reproduction

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-04-23
Device Publish Date2018-06-19

Devices Manufactured by GENEA BIOMEDX PTY LTD

29348265003011 - Geri Dish2021-03-10 The Geri Dish is intended to be used for preparation, storage and imaging of human embryos. The Geri Dish is intended to be used
09348265003048 - Geri Water Bottle2019-10-23 The Geri Water Bottle is a two-piece (base and top) item, manufactured by injection molding in polystyrene material.
09348265003024 - Geri Connect Server (including software)2019-04-23 Geri Connect & Geri Assess connects one or more Geri incubators through a LAN. The Geri Connect & Geri Assess software enables m
09348265003079 - Geri Software Connect and Assess 1.32019-04-23 Geri Connect & Geri Assess connects one or more Geri incubators through a LAN. The Geri Connect & Geri Assess software enables m
09348265003086 - Geri Software Connect and Assess 2.02019-04-23Geri 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.
09348265003086 - Geri Software Connect and Assess 2.02019-04-23 Geri Connect & Geri Assess connects one or more Geri incubators through a LAN. The Geri Connect & Geri Assess software enables m

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