BIOCUE® 800-0615

GUDID 00880304640924

Biomet Biologics, LLC

Haematological concentrate system

• Primary Device ID: 00880304640924
• NIH Device Record Key: ef50480b-9e47-40bb-9e3f-d6a9395a456a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOCUE®
• Version Model Number: 800-0615
• Catalog Number: 800-0615
• 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: 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

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	00880304640924 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK100027

FDA Product Code

• FMF: Syringe, piston
• 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-03

On-Brand Devices [BIOCUE®]

• 00880304640924: 800-0615
• 00880304640917: 800-0614