GUDID 20673978538420

CELL 1475R1 TMC50 W/6 INCH EXTENSION

MEDTRONIC, INC.

Extracorporeal membrane oxygenator
Primary Device ID20673978538420
NIH Device Record Keyc7a9208a-266e-488e-a0f2-ec092220b3b6
Commercial Distribution StatusIn Commercial Distribution
Version Model Number1475R1
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 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
GS100673978538426 [Primary]
GS120673978538420 [Package]
Contains: 00673978538426
Package: PK [12 Units]
In Commercial Distribution

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 Number4
Public Version Date2020-01-22
Device Publish Date2016-09-04

Devices Manufactured by MEDTRONIC, INC.

00199150030842 - NA2025-07-15 CUSTOM PACK BB8B05R17 HBC
00199150026654 - NA2025-07-07 CUSTOM PACK BB11E82R2 CB E SUPP
00199150026661 - NA2025-07-07 CUSTOM PACK BB7D23R7 RADL
00199150026722 - NA2025-07-07 CUSTOM PACK BB8T30R14 3/8 COMER
00199150026739 - NA2025-07-07 CUSTOM PACK BB12B00R3 3/8 SUPPORT
20199150026887 - NA2025-07-07 CUSTOM PACK BB8M18R1 2PK 1/4 LINES
00199150026890 - NA2025-07-07 CUSTOM PACK BB6U14R7 TABLE PK
00199150026906 - NA2025-07-07 CUSTOM PACK BB11S65R3 UAB L U N G T

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