Intelliflow™

GUDID 00613994384034

CONTROL IRD200 IPC IRRIGATION REMOTE

MEDTRONIC XOMED, INC.

Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use

• Primary Device ID: 00613994384034
• NIH Device Record Key: 66eab1bf-927c-4dd0-9d1e-418f45c89233
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intelliflow™
• Version Model Number: IRD200
• Company DUNS: 835465063
• Company Name: MEDTRONIC XOMED, 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: 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)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994384034 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081475

FDA Product Code

• HBE: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-07-04

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