GUDID 20673978538383

CELL 1473R1 TMC25 W/6 IN EXTENSION

MEDTRONIC, INC.

Extracorporeal membrane oxygenator
Primary Device ID20673978538383
NIH Device Record Keyfd7206ba-86d5-4d62-a936-932f82a569c3
Commercial Distribution StatusIn Commercial Distribution
Version Model Number1473R1
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count12
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100673978538389 [Unit of Use]
GS120673978538383 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRYMONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-01-22
Device Publish Date2018-12-22

Devices Manufactured by MEDTRONIC, INC.

00199150036998 - NA2025-08-08 CUSTOM PACK BB6H41R30 LESS 20K
00199150037643 - NA2025-08-08 CUSTOM PACK BB4941R6 SUPPORT
00199150037650 - NA2025-08-08 CUSTOM PACK BB12Q72R SEQ ADLT COMBO
00199150037711 - NA2025-08-08 CUSTOM PACK BB7M47R9 ADULT
20199150037739 - NA2025-08-08 CUSTOM PACK BB10M84R3 5PK AVL 3/8
20199150037753 - NA2025-08-08 CUSTOM PACK BB12R03R 20PK ACC 1/4X3/8X3/
00199150037773 - NA2025-08-08 CUSTOM PACK BB9E90R10 3/8 SPRT P
20199150038019 - NA2025-08-08 CUSTOM PACK 7P25R6 4PK CARDPLEGIAM

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