BACT/ALERT® BPN

GUDID 03573026126735

BacT/ALERT BPN (anaerobic culture) bottles: 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

• Primary Device ID: 03573026126735
• NIH Device Record Key: 1aaa67e6-3981-4e00-92f7-b9a5d2ef0d79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BACT/ALERT® BPN
• Version Model Number: BACT/ALERT® BPN
• 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	03573026126735 [Package]; Contains: 03573026611866; Package: [2 Units]; In Commercial Distribution
GS1	03573026595999 [Primary]
GS1	03573026611866 [Package]; Contains: 03573026595999; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• BK050043

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: 2020-05-05
• Device Publish Date: 2020-04-27

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