BioCUE® Concentration System 800-0611A

GUDID 00880304681484

Biomet Biologics, LLC

Haematological concentrate system

• Primary Device ID: 00880304681484
• NIH Device Record Key: a2036825-1f6b-4a64-b954-18044054ffc2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioCUE® Concentration System
• Version Model Number: 800-0611A
• Catalog Number: 800-0611A
• Company DUNS: 802003074
• Company Name: Biomet Biologics, LLC
• 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

Customer Support Contacts

• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304681484 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK100027

FDA Product Code

• JQC: CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-01-24
• Device Publish Date: 2018-11-14

Devices Manufactured by Biomet Biologics, LLC

• 00880304640962 - Bilateral BMA Kit: 2021-11-08
• 00880304460645 - GPS® III: 2020-02-05
• 00880304460652 - GPS® III: 2020-02-05
• 00880304681477 - BioCUE® Mini Concentration System: 2020-01-24
• 00880304681484 - BioCUE® Concentration System: 2020-01-24
• 00880304681484 - BioCUE® Concentration System: 2020-01-24
• 00880304680333 - PERFUSE DECOMPRESSION INSTRUMENTATION: 2019-08-09
• 00880304400085 - Biomet®: 2019-06-19
• 00880304400092 - Plasmax® Counterbalance: 2019-06-19