BACT/ALERT®

GUDID 03573026616694

Culture Bottles are used with the BacT/ALERT Microbial Detection System in qualitative procedures for enhanced recovery and detection of a variety of anaerobic and facultative microorganisms

BIOMERIEUX , INC.

Blood culture broth kit IVD

• Primary Device ID: 03573026616694
• NIH Device Record Key: f5a458b2-e818-4673-9a4d-09d3549c381f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BACT/ALERT®
• Version Model Number: BACT/ALERT®
• 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: true
• 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
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026209360 [Package]; Package: [1 Units]; In Commercial Distribution
GS1	03573026616694 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020931

FDA Product Code

• GIM: Tubes, vacuum sample, with anticoagulant

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: 2020-04-27
• Device Publish Date: 2020-04-17

On-Brand Devices [BACT/ALERT®]

• 03573026616694: Culture Bottles are used with the BacT/ALERT Microbial Detection System in qualitative procedure
• 03573026611323: BACT/ALERT BPN (anaerobic culture) bottles: used for QC testing of leukocyte reduced apheresis p
• 03573026614140: BACT/ALERT BPA (aerobic culture) bottles are used for QC testing of leukocyte reduced apheresis