BACT/ALERT VIRTUO

GUDID 03573026614546

Firmware update for VIRTUO Release R 3.0

BIOMERIEUX , INC.

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• Primary Device ID: 03573026614546
• NIH Device Record Key: e72d60f7-d34b-4db4-b71a-5855d3bab62b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BACT/ALERT VIRTUO
• Version Model Number: R3
• Company DUNS: 086785110
• Company Name: BIOMERIEUX , INC.
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• 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	03573026614546 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161816

FDA Product Code

• MDB: System, blood culturing

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-04
• Device Publish Date: 2020-08-27

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