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

GUDID 20613994495468

CANNULA 11012L AR FLOWGUARD LNG 12GA 10P

MEDTRONIC, INC.

Cardioplegia cannula
Primary Device ID20613994495468
NIH Device Record Keye5773492-2b02-430d-885b-fbe640c45e58
Commercial Distribution StatusIn Commercial Distribution
Brand NameMi¯AR™ Aortic Root Cannula with Flow-Guard™
Version Model Number11012L
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Catheter Gauge9 French
Catheter Gauge9 French
Catheter Gauge9 French
Catheter Gauge9 French
Catheter Gauge9 French
Catheter Gauge9 French
Catheter Gauge9 French
Catheter Gauge9 French
Catheter Gauge9 French
Catheter Gauge9 French
Catheter Gauge9 French
Catheter Gauge9 French
Catheter Gauge9 French
Catheter Gauge9 French
Catheter Gauge9 French
Catheter Gauge9 French
Catheter Gauge9 French
Catheter Gauge9 French
Catheter Gauge9 French
Catheter Gauge9 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994495464 [Unit of Use]
GS120613994495468 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-05-21

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

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

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