GUDID 10673978522460

ADAPTER BT920 CARDIOTOMY TANDEM Y 10PK

MEDTRONIC, INC.

Red blood cell-recovery autotransfusion system set
Primary Device ID10673978522460
NIH Device Record Keyedcc46e7-d926-4b1c-a6e0-a4526b52631a
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberBT920
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
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
GS100673978522463 [Unit of Use]
GS110673978522460 [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 Date2021-01-08
Device Publish Date2016-09-04

Devices Manufactured by MEDTRONIC, INC.

00199150025381 - NA2025-06-27 CUSTOM PACK BB11P25R3 VCH CENT V A
20199150025521 - NA2025-06-27 CUSTOM PACK BB9G37R2 5PK L VD AC
00199150026326 - NA2025-06-27 CUSTOM PACK BB11Z33R8 ALINA CPB
00199150026579 - NA2025-06-27 CUSTOM PACK BB5722R48 CHRT INF
00199150026692 - NA2025-06-27 CUSTOM PACK BB8R73R14 NH ADULT PACK
00199150026715 - NA2025-06-27 CUSTOM PACK BB6M71R12 CP PRIME
00199150026746 - NA2025-06-27 CUSTOM PACK BB7A25R12 PED
00199150026753 - NA2025-06-27 CUSTOM PACK BB12E34R4 SUPPORT PACK

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