BacT/ALERT®3D

GUDID 03573026535476

BactT/ALERT 3D B.50 Installation Kit, English, USB

BIOMERIEUX , INC.

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• Primary Device ID: 03573026535476
• NIH Device Record Key: d2dc7ea7-7a1d-42ed-8e07-c341f1e06846
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BacT/ALERT®3D
• Version Model Number: B.50
• 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	03573026535476 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K903505

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: 2020-12-28
• Device Publish Date: 2020-12-18

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