GUDID 20673978523570

CARDIOTOMY EL400 4 LITER 120 MICRON

MEDTRONIC, INC.

Cardiotomy reservoir
Primary Device ID20673978523570
NIH Device Record Keye96ba8b9-eb74-4e1c-9f5c-56526dac97e5
Commercial Distribution Discontinuation2018-10-05
Commercial Distribution StatusNot in Commercial Distribution
Version Model NumberEL400
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 Dimensions

Pore Size120 Micrometer
Pore Size120 Micrometer

Device Identifiers

Device Issuing AgencyDevice ID
GS100673978523576 [Primary]
GS120673978523570 [Package]
Contains: 00673978523576
Package: PK [6 Units]
Discontinued: 2018-10-05
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTNRESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-01-22
Device Publish Date2016-06-16

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