REDI-FLOW FILTER® SYSTEM 631042

GUDID 00880304398498

Biomet Orthopedics, LLC

General-purpose suction system, line-powered

• Primary Device ID: 00880304398498
• NIH Device Record Key: 89dc74a1-34ca-46d8-8e5f-ad80cc2bcc55
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REDI-FLOW FILTER® SYSTEM
• Version Model Number: 631042
• Catalog Number: 631042
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, 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: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00880304398498 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K790209

FDA Product Code

• GAZ: TUBING, NONINVASIVE

Sterilization

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

[00880304398498]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-26

On-Brand Devices [REDI-FLOW FILTER® SYSTEM]

• 00880304731370: 631022
• 00880304398498: 631042
• 00880304398481: 631041
• 00880304398443: 631031