2nd Gen CentriMag Primary Console 201-90411

GUDID 07640135140702

Thoratec Switzerland GmbH

Cardiopulmonary bypass system centrifugal pump drive unit
Primary Device ID07640135140702
NIH Device Record Key8445fbb1-0adf-490c-9f99-434d26add19e
Commercial Distribution StatusIn Commercial Distribution
Brand Name2nd Gen CentriMag Primary Console
Version Model Number201-90411
Catalog Number201-90411
Company DUNS486066918
Company NameThoratec Switzerland GmbH
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(855)478-5833
Emailcustomerservice@sjm.com

Operating and Storage Conditions

Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70.2 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107640135140702 [Primary]

FDA Product Code

DWAControl, Pump Speed, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-02-06
Device Publish Date2014-09-20

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