DLP® Aortic Root Cannula with Flow-Guard™ Introduc

GUDID 20613994495406

CANNULA 21014 AR VENT FLOW 14GA 20PK 17L

MEDTRONIC, INC.

Cardioplegia cannula

• Primary Device ID: 20613994495406
• NIH Device Record Key: fdb77bde-283a-4a69-b938-13c342fc9104
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DLP® Aortic Root Cannula with Flow-Guard™ Introduc
• Version Model Number: 21014
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 20
• 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: false
• 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 Dimensions

• Catheter Gauge: 7 French
• Catheter Gauge: 7 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994495402 [Unit of Use]
GS1	20613994495406 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K810548

FDA Product Code

• DWF: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

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: 2016-05-22

On-Brand Devices [DLP® Aortic Root Cannula with Flow-Guard™ Introduc]

• 20613994495406: CANNULA 21014 AR VENT FLOW 14GA 20PK 17L
• 20613994495390: CANNULA 21012 AR VENT FLOW 12GA 20PK 17L