Geri Water Bottle

GUDID 09348265003048

The Geri Water Bottle is a two-piece (base and top) item, manufactured by injection molding in polystyrene material.

GENEA BIOMEDX PTY LTD

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• Primary Device ID: 09348265003048
• NIH Device Record Key: 2b042c3b-18fd-44f4-a1ad-18968c6b29ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Geri Water Bottle
• Version Model Number: GERI-WAT-01
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09348265003048 [Primary]
GS1	19348265003045 [Package]; Package: [12 Units]; In Commercial Distribution
GS1	29348265003042 [Package]; Contains: 19348265003045; Package: [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180304

FDA Product Code

• MQK: Labware, Assisted Reproduction

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-23
• Device Publish Date: 2018-05-04

Devices Manufactured by GENEA BIOMEDX PTY LTD

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• 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.
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• 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: 2019-04-23 Geri Connect & Geri Assess connects one or more Geri incubators through a LAN. The Geri Connect & Geri Assess software enables m