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 ID: 09348265003086
• NIH Device Record Key: 35a073df-e1e6-4cea-8a7a-8a3613f9eec2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Geri Software Connect and Assess 2.0
• Version Model Number: GERI-SCA-05
• Company DUNS: 752103403
• Company Name: GENEA BIOMEDX PTY LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09348265003086 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180188

FDA Product Code

• MQG: Accessory, Assisted Reproduction

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-04-23
• Device Publish Date: 2018-06-19

Devices Manufactured by GENEA BIOMEDX PTY LTD

• 29348265003011 - Geri Dish: 2021-03-10 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 Bottle: 2019-10-23 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 1.3: 2019-04-23 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 2.0: 2019-04-23Geri 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 2.0: 2019-04-23 Geri Connect & Geri Assess connects one or more Geri incubators through a LAN. The Geri Connect & Geri Assess software enables m