VISIONIST™ X4 CRT-P

GUDID 00802526559471

Cardiac Resynchronization Therapy Pacemaker

BOSTON SCIENTIFIC CORPORATION

Cardiac resynchronization therapy implantable pacemaker
Primary Device ID00802526559471
NIH Device Record Key7937e6e9-fab0-427d-a9c0-2eac518d1cbb
Commercial Distribution StatusIn Commercial Distribution
Brand NameVISIONIST™ X4 CRT-P
Version Model NumberU228
Company DUNS106295384
Company NameBOSTON SCIENTIFIC CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100802526559471 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKEPulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2017-03-09

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

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Trademark Results [VISIONIST]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VISIONIST
VISIONIST
98003132 not registered Live/Pending
Luxury Optical Holdings Co.
2023-05-18
VISIONIST
VISIONIST
90976814 not registered Live/Pending
Luxury Optical Holdings Co.
2021-04-28
VISIONIST
VISIONIST
90677226 not registered Live/Pending
Luxury Optical Holdings Co.
2021-04-28
VISIONIST
VISIONIST
88753491 not registered Live/Pending
Alford, Cornelius
2020-01-09
VISIONIST
VISIONIST
87093326 5277789 Live/Registered
Cardiac Pacemakers, Inc.
2016-07-05
VISIONIST
VISIONIST
85873726 not registered Dead/Abandoned
Cardiac Pacemakers, Inc.
2013-03-12

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