LUX-Dx™ Insertable Cardiac Monitor 60M301-101

GUDID 00802526607103

LUX-Dx Insertable Cardiac Monitor

BOSTON SCIENTIFIC CORPORATION

Implantable cardiac monitor
Primary Device ID00802526607103
NIH Device Record Keyd424f4c6-1c56-440a-b773-4f18d6798912
Commercial Distribution StatusIn Commercial Distribution
Brand NameLUX-Dx™ Insertable Cardiac Monitor
Version Model NumberM301
Catalog Number60M301-101
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 Datetrue
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
GS100802526607103 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MXDRecorder, event, implantable cardiac, (with arrhythmia detection)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-09
Device Publish Date2020-07-01

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

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00191506046408 - Sterling™2025-03-31 PTA Balloon Dilatation Catheter

Trademark Results [LUX-Dx]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LUX-DX
LUX-DX
87569443 not registered Dead/Abandoned
Cardiac Pacemakers, Inc.
2017-08-15

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