ORIGEN™ X4 CRT-D

GUDID 00802526534492

Cardiac Resynchronization Therapy Defibrillator

BOSTON SCIENTIFIC CORPORATION

Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator
Primary Device ID00802526534492
NIH Device Record Key944332d3-8274-4b8a-82f7-5689219201cd
Commercial Distribution StatusIn Commercial Distribution
Brand NameORIGEN™ X4 CRT-D
Version Model NumberG056
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
GS100802526534492 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NIKDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-12-06
Device Publish Date2017-11-03

On-Brand Devices [ORIGEN™ X4 CRT-D]

00802526534515Cardiac Resynchronization Therapy Defibrillator
00802526534492Cardiac Resynchronization Therapy Defibrillator

Trademark Results [ORIGEN]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ORIGEN
ORIGEN
97376177 not registered Live/Pending
WANG, Quo Qi
2022-04-22
ORIGEN
ORIGEN
88950642 not registered Live/Pending
Tenaska Power Services Co.
2020-06-05
ORIGEN
ORIGEN
88413884 not registered Live/Pending
SNHO Spirits LLC
2019-05-03
ORIGEN
ORIGEN
87499830 5587337 Live/Registered
PENGUIN RANDOM HOUSE GRUPO EDITORIAL USA LLC
2017-06-21
ORIGEN
ORIGEN
86796400 not registered Dead/Abandoned
Estrada García, Karla
2015-10-22
ORIGEN
ORIGEN
86575757 5239009 Live/Registered
3T BRANDS, INC.
2015-03-25
ORIGEN
ORIGEN
86139221 4635839 Live/Registered
Omni International Trading Corp.
2013-12-10
ORIGEN
ORIGEN
86012915 4611005 Live/Registered
Ceres Inc.
2013-07-17
ORIGEN
ORIGEN
85885233 not registered Dead/Abandoned
Triboro Quilt Manufacturing Corp.
2013-03-25
ORIGEN
ORIGEN
85608174 not registered Dead/Abandoned
Boston Scientific Scimed, Inc.
2012-04-25
ORIGEN
ORIGEN
85602530 4304193 Dead/Cancelled
Moux Trading Corporation
2012-04-19
ORIGEN
ORIGEN
85553743 4562121 Live/Registered
IDT TELECOM, INC.
2012-02-27

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