GUDID 00613994462695

CUSTOM PACK 5U66R HL

MEDTRONIC, INC.

Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set
Primary Device ID00613994462695
NIH Device Record Key196e3d2b-cc33-4f9b-bf38-52c1e98f6733
Commercial Distribution Discontinuation2018-10-05
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number5U66R
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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 Perscriptiontrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994462695 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWETUBING, PUMP, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-12-19
Device Publish Date2016-07-29

Devices Manufactured by MEDTRONIC, INC.

00763000451868 - SenSight™2024-06-24 ACCY B31030 EXT TNLR DBS PAPER LJ55
00763000956578 - NA2024-06-24 CUSTOM PACK BB10U97R11 FUS W/MYO
00763000957292 - NA2024-06-24 CUSTOM PACK BB12F66R5 1/4 EC PACK
00763000957537 - NA2024-06-24 CUSTOM PACK BB7V77R17 MCS3/8X3/8
00763000957568 - NA2024-06-24 CUSTOM PACK HY12E20R5 HEART LUNG PA
00763000892067 - InterStim™ X2024-06-18 INS 97800 INTERSTIM X SSMRI GLOBAL EMAN
00763000957308 - NA2024-06-18 CUSTOM PACK BB4Z62R22 ADLT 1/2
00763000956561 - NA2024-06-17 CUSTOM PACK BB12A95R2 NAVICENT MDT

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.