FORMIO™

GUDID 00802526517259

Pacemaker

BOSTON SCIENTIFIC CORPORATION

Dual-chamber implantable pacemaker, rate-responsive
Primary Device ID00802526517259
NIH Device Record Key02bab921-9466-4990-8691-ea690e5c4366
Commercial Distribution StatusIn Commercial Distribution
Brand NameFORMIO™
Version Model NumberK278
Company DUNS106295384
Company NameBOSTON SCIENTIFIC CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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
GS100802526517259 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWPImplantable pulse generator, pacemaker (non-CRT)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-12-11
Device Publish Date2014-09-24

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Trademark Results [FORMIO]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FORMIO
FORMIO
87450036 not registered Dead/Abandoned
Cardiac Pacemakers, Inc.
2017-05-15
FORMIO
FORMIO
86124570 not registered Dead/Abandoned
Cardiac Pacemakers, Inc.
2013-11-20
FORMIO
FORMIO
76703294 not registered Dead/Abandoned
Cardiac Pacemakers, Inc.
2010-06-08

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