HeartMate II®, System Controller 10005080

GUDID 00813024013013

System Controller

Thoratec Corporation

Implantable ventricular circulatory assist system control unit Implantable ventricular circulatory assist system control unit Implantable ventricular circulatory assist system control unit Implantable ventricular circulatory assist system control unit Implantable ventricular circulatory assist system control unit Implantable ventricular circulatory assist system control unit Implantable ventricular circulatory assist system control unit Implantable ventricular circulatory assist system control unit Implantable ventricular circulatory assist system control unit Implantable ventricular circulatory assist system control unit Implantable ventricular circulatory assist system control unit Implantable ventricular circulatory assist system control unit Implantable ventricular circulatory assist system control unit Implantable ventricular circulatory assist system control unit
Primary Device ID00813024013013
NIH Device Record Key321795f0-1193-4e7b-9616-b99f725b1c88
Commercial Distribution StatusIn Commercial Distribution
Brand NameHeartMate II®, System Controller
Version Model Number10005080
Catalog Number10005080
Company DUNS070156955
Company NameThoratec Corporation
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 Batchfalse
Serial Numbertrue
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
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100813024013013 [Primary]

FDA Product Code

DSQVentricular (Assisst) Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-04-01
Device Publish Date2017-03-31

On-Brand Devices [HeartMate II®, System Controller]

00813024013013System Controller
00813024012542105472
00813024012528System Controller

Trademark Results [HeartMate II]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HEARTMATE II
HEARTMATE II
76630940 3165758 Live/Registered
Thoratec Corporation
2005-02-10

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