GUDID 00673978537467

CONNECTOR 1392 HANSEN QUICK W/TUBING

MEDTRONIC, INC.

Cardiopulmonary bypass system temperature control unit Cardiopulmonary bypass system temperature control unit
Primary Device ID00673978537467
NIH Device Record Key12e4bab7-42d9-4ffd-be19-1dec1d712e49
Commercial Distribution StatusIn Commercial Distribution
Version Model Number1392
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 Usefalse
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
GS100673978537467 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWJSYSTEM, THERMAL REGULATING

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-05-02

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