TLC-II® SYSTEM DRIVER 100621

GUDID 00813024013396

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
Primary Device ID00813024013396
NIH Device Record Keyd0d5067a-0b64-48ac-923d-8a63636713a6
Commercial Distribution StatusIn Commercial Distribution
Brand NameTLC-II® SYSTEM DRIVER
Version Model Number100621
Catalog Number100621
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 Usefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100813024013396 [Primary]

FDA Product Code

DSQVentricular (Assisst) Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number7
Public Version Date2019-03-21
Device Publish Date2014-09-20

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05415067033758 - HeartMate Touch™2020-07-02 Communication System
05415067032058 - HeartMate Touch™2020-05-12 Communication System

Trademark Results [TLC-II]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TLC-II
TLC-II
75484263 2406798 Live/Registered
THORATEC CORPORATION
1998-05-13

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