Mi¯AR™ Aortic Root Cannula with Flow-Guard™

GUDID 20613994495499

CANNULA 11014L AR FLOWGUARD 14GA LONG

MEDTRONIC, INC.

Cardioplegia cannula Cardioplegia cannula Cardioplegia cannula Cardioplegia cannula Cardioplegia cannula Cardioplegia cannula Cardioplegia cannula Cardioplegia cannula Cardioplegia cannula Cardioplegia cannula Cardioplegia cannula Cardioplegia cannula Cardioplegia cannula Cardioplegia cannula Cardioplegia cannula Cardioplegia cannula Cardioplegia cannula Cardioplegia cannula Cardioplegia cannula Cardioplegia cannula

• Primary Device ID: 20613994495499
• NIH Device Record Key: 38434d51-1ce1-4b20-9207-4d49f717b2c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mi¯AR™ Aortic Root Cannula with Flow-Guard™
• Version Model Number: 11014L
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 10
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• 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
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994495495 [Unit of Use]
GS1	20613994495499 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100274
• 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: 2016-05-22

On-Brand Devices [Mi¯AR™ Aortic Root Cannula with Flow-Guard™]

• 20613994495499: CANNULA 11014L AR FLOWGUARD 14GA LONG
• 20613994495468: CANNULA 11012L AR FLOWGUARD LNG 12GA 10P