Corox 354805

GUDID 04035479093532

BIOTRONIK SE & Co. KG

Coronary venous pacing lead
Primary Device ID04035479093532
NIH Device Record Keya9fa9659-5fac-449c-bffd-59b75d27e001
Commercial Distribution StatusIn Commercial Distribution
Brand NameCorox
Version Model NumberOTW 75-BP
Catalog Number354805
Company DUNS315620229
Company NameBIOTRONIK SE & Co. KG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
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

Customer Support Contacts

Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com

Device Dimensions

Device Size Text, specify0
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Device Size Text, specify0
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Device Size Text, specify0
Device Size Text, specify0
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Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS104035479093532 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OJXDrug eluting permanent left ventricular (lv) pacemaker electrode

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-02-05
Device Publish Date2014-08-06

On-Brand Devices [Corox]

04035479112172OTW-L 85-BP
04035479112165OTW-L 75-BP
04035479094164OTW-S 85-BP
04035479094157OTW-S 75-BP
04035479093549OTW 85-BP
04035479093532OTW 75-BP

Trademark Results [Corox]

Mark Image

Registration | Serial
Company
Trademark
Application Date
COROX
COROX
79231823 5663656 Live/Registered
Linde Aktiengesellschaft
2018-03-19
COROX
COROX
74259877 not registered Dead/Abandoned
CardioPulmonics, Inc.
1992-03-27
COROX
COROX
71318471 0294201 Dead/Expired
WESTINGHOUSE ELECTRIC AND MANUFACTURINGCOMPANY
1931-08-26

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