GUDID 20613994728566

CANNULA KIT DLP3L61R2 5PK DR DELAG

MEDTRONIC, INC.

Cardiopulmonary bypass system tubing set
Primary Device ID20613994728566
NIH Device Record Key37793d18-2aaa-4208-a427-b114d78b27d9
Commercial Distribution Discontinuation2018-10-24
Commercial Distribution StatusNot in Commercial Distribution
Version Model NumberDLP3L61R2
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994728562 [Primary]
GS120613994728566 [Package]
Contains: 00613994728562
Package: PK [5 Units]
Discontinued: 2018-10-24
Not in Commercial Distribution

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 Number4
Public Version Date2018-12-11
Device Publish Date2016-05-21

Devices Manufactured by MEDTRONIC, INC.

00199150050161 - NA2025-09-29 CUSTOM PACK HLO BB12D44R4 PUMP PK
00199150050178 - NA2025-09-29 CUSTOM PACK BB4W67R26 EVL ADULT E
00199150050185 - NA2025-09-29 CUSTOM PACK BB4Q12R27 UNIV H/L
20199150050202 - NA2025-09-29 CUSTOM PACK BB12P63R 4PK GPS TABLE PK
00199150050871 - NA2025-09-29 CUSTOM PACK BB11R66R2 TBL 1/4
00763000877033 - SPRINTER® LEGEND2025-09-29 BALLOON SPL15006X SPR LEG RX US M
00763000877040 - SPRINTER® LEGEND2025-09-29 BALLOON SPL15010X SPR LEG RX US M
00763000877057 - SPRINTER® LEGEND2025-09-29 BALLOON SPL15012X SPR LEG RX US M

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.