THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS) 106015

GUDID 00813024011224

Thoratec Corporation

Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system
Primary Device ID00813024011224
NIH Device Record Key4e4df315-85e0-405e-bc60-3cf1f0f3e16e
Commercial Distribution StatusIn Commercial Distribution
Brand NameTHORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS)
Version Model Number106015
Catalog Number106015
Company DUNS070156955
Company NameThoratec Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
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
Phone+1(855)478-5833
Emailcustomerservice@sjm.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100813024011224 [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 Number5
Public Version Date2019-05-15
Device Publish Date2014-09-20

Devices Manufactured by Thoratec Corporation

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05415067038760 - HeartMate 3™2022-06-22 Coring Tool
05415067039286 - HeartMate 3™2022-06-22 Apical Cuff
05415067039361 - HeartMate 3™2022-06-22 Skin Coring Punch
15415067039481 - HeartMate 3™2022-06-22 Thread Protectors
05415067033758 - HeartMate Touch™2020-07-02 Communication System
05415067032058 - HeartMate Touch™2020-05-12 Communication System

Trademark Results [THORATEC]

Mark Image

Registration | Serial
Company
Trademark
Application Date
THORATEC
THORATEC
85978341 4401802 Live/Registered
Thoratec Corporation
2011-05-19
THORATEC
THORATEC
85324767 not registered Dead/Abandoned
Thoratec Corporation
2011-05-19
THORATEC
THORATEC
74723471 2052014 Dead/Cancelled
Thoratec Laboratories Corporation
1995-08-30
THORATEC
THORATEC
74353279 1794636 Live/Registered
THORATEC CORPORATION
1993-01-28

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