METAL LOCKING FEATURE FOR CENTRIMAG MOTOR 104326

GUDID 07640135140405

Thoratec Switzerland GmbH

Cardiopulmonary bypass system centrifugal pump drive unit
Primary Device ID07640135140405
NIH Device Record Key97cb7bbe-df5b-4354-91cb-3256c851d7e4
Commercial Distribution StatusIn Commercial Distribution
Brand NameMETAL LOCKING FEATURE FOR CENTRIMAG MOTOR
Version Model Number104326
Catalog Number104326
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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 TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 79.3 KiloPascal and 101.3 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS107640135140405 [Primary]

FDA Product Code

KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-06
Device Publish Date2014-09-20

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