UL-DU28-00S-ER

GUDID 00889024471214

ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.

Surgical fluid/smoke waste management system suction unit

• Primary Device ID: 00889024471214
• NIH Device Record Key: a5c9e422-589c-4023-844b-2df35458c68b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: UL-DU2800SER
• Catalog Number: UL-DU28-00S-ER
• Company DUNS: 137354267
• Company Name: ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024471214 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081047

FDA Product Code

• JCX: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Sterilization

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

[00889024471214]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-14
• Device Publish Date: 2017-02-01

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