Thoratec® HeartMate 3™ 106522US

GUDID 05415067030801

Apical Cuff

Thoratec Corporation

Implantable ventricular circulatory assist system
Primary Device ID05415067030801
NIH Device Record Key37b4812c-2049-4d7a-aa10-42cee984160e
Commercial Distribution StatusIn Commercial Distribution
Brand NameThoratec® HeartMate 3™
Version Model Number106522US
Catalog Number106522US
Company DUNS070156955
Company NameThoratec Corporation
Device Count3
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100813024012825 [Unit of Use]
GS105415067030801 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSQVentricular (assist) bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-31
Device Publish Date2019-05-23

On-Brand Devices [Thoratec® HeartMate 3™]

00813024013082Mini Apical Cuff Kit
00813024013075Coring Tool
05415067031105System Controller Low Flow 2.0
05415067030368Tunneling Adapter
05415067030825Skin Coring Punch
05415067030818Thread Protectors
05415067030801Apical Cuff
00813024013143Tunneling Lance and Handle

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.