BACT/ALERT® FN PLUS

GUDID 03573026357917

The BACT/ALERT FN Plus Culture Bottles are used for the recovery and detection of anaerobic,facultative anaerobic microorganisms from blood and other normally sterile body fluids

BIOMERIEUX , INC.

Basic/simple nutrient broth culture medium IVD

• Primary Device ID: 03573026357917
• NIH Device Record Key: c0561ba0-bd42-478f-b379-aa2da6b69484
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BACT/ALERT® FN PLUS
• Version Model Number: BACT/ALERT® FN PLUS
• 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026357917 [Package]; Contains: 03573026611903; Package: [2 Units]; In Commercial Distribution
GS1	03573026596071 [Primary]
GS1	03573026611903 [Package]; Contains: 03573026596071; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121455

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: 2020-05-01
• Device Publish Date: 2020-04-23

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