BACT/ALERT®

GUDID 03573026614140

BACT/ALERT BPA (aerobic culture) bottles are used for QC testing of leukocyte reduced apheresis platelet units,leukocyte reduced single units of whole blood platelet concentrates

BIOMERIEUX , INC.

Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD

• Primary Device ID: 03573026614140
• NIH Device Record Key: 561ec086-9b78-45f4-9961-f6e8f746bcd2
• 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: 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
• 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
• 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
• 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	03573026611316 [Package]; Package: [4 Units]; In Commercial Distribution
GS1	03573026612047 [Primary]
GS1	03573026614140 [Package]; Contains: 03573026612047; Package: [50 Units]; In Commercial Distribution

FDA Product Code

• MZC: System, detection, bacterial, for platelet transfusion products

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: 2020-07-06
• Device Publish Date: 2020-06-26

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