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

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00763000988258 - NA2024-12-20 CUSTOM PACK BB10Q85R1 FILTER
00763000988760 - NA2024-12-20 CUSTOM PACK BB1F66R26 CASPER
00763000973391 - Sphere-9™ Catheter2024-12-16 CATHETER AFR-00001 SPHERE 9 Q-US AFR
00763000986704 - NA2024-12-09 CUSTOM PACK BB7J97R20 1/4 PED CIRC
00763000986773 - NA2024-12-09 CUSTOM PACK BB11N26R12 MASTER PACK
20763000986814 - NA2024-12-09 CUSTOM PACK BB12G70R3 10PK SUPPLIES

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