DLP® Aortic Root Cannula with Flow-Guard™

GUDID 20613994495451

CANNULA 11012 AR FLOWGUARD 12GA 20PK 17L

MEDTRONIC, INC.

Cardioplegia cannula

• Primary Device ID: 20613994495451
• NIH Device Record Key: dc734f15-e7a8-409b-9035-d06de6669569
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DLP® Aortic Root Cannula with Flow-Guard™
• Version Model Number: 11012
• 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: 9 French
• Catheter Gauge: 9 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994495457 [Unit of Use]
GS1	20613994495451 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K790565

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: 2016-05-21

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

• 00673978861494: CANN CB11014 DLP 14 GA AORTIC ROOT
• 00673978861487: CANNULA CB11012 AR FLOWGUARD 12GA 10L
• 20613994495482: CANNULA 11014 AR FLOWGUARD 14GA 20PK 17L
• 20613994495451: CANNULA 11012 AR FLOWGUARD 12GA 20PK 17L