CapSure Sense®

GUDID 00643169590540

LEAD 407485 CAPSURE SENSE US BI RCMCRD

MEDTRONIC, INC.

Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead
Primary Device ID00643169590540
NIH Device Record Key278a55ae-ba81-40ef-8a76-68d57f9a1fe5
Commercial Distribution StatusIn Commercial Distribution
Brand NameCapSure Sense®
Version Model Number407485
Company DUNS006261481
Company NameMEDTRONIC, INC.
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Length85 Centimeter
Length85 Centimeter
Length85 Centimeter
Length85 Centimeter
Length85 Centimeter
Length85 Centimeter
Length85 Centimeter
Length85 Centimeter
Length85 Centimeter
Length85 Centimeter
Length85 Centimeter
Length85 Centimeter
Length85 Centimeter
Length85 Centimeter
Length85 Centimeter
Length85 Centimeter
Length85 Centimeter
Length85 Centimeter
Length85 Centimeter
Length85 Centimeter
Length85 Centimeter
Length85 Centimeter
Length85 Centimeter
Length85 Centimeter
Length85 Centimeter
Length85 Centimeter
Length85 Centimeter
Length85 Centimeter
Length85 Centimeter
Length85 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169590540 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTBpermanent pacemaker Electrode

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-01-14

On-Brand Devices [CapSure Sense®]

00643169590540LEAD 407485 CAPSURE SENSE US BI RCMCRD
00643169590533LEAD 407465 CAPSURE SENSE US BI RCMCRD
00643169590526LEAD 407458 CAPSURE SENSE US BI RCMCRD
00643169590519LEAD 407452 CAPSURE SENSE US BI RCMCRD
00643169590502LEAD 407445 CAPSURE SENSE US BI RCMCRD
00643169590496LEAD 407365 US UNI RCMCRD
00643169590489LEAD 407345 US UNI RCMCRD
00643169590472LEAD 407358 US UNI RCMCRD
00643169590465LEAD 407352 US UNI RCMCRD
00643169411104LEAD 407485 US BI RCMCRD
00643169411098LEAD 407465 US BI RCMCRD
00643169411081LEAD 407458 US BI RCMCRD
00643169411074LEAD 407452 US BI RCMCRD
00643169411067LEAD 407445 US BI RCMCRD
00643169411029LEAD 407358 US UNI RCMCRD
00643169411012LEAD 407352 US UNI RCMCRD
00643169410985LEAD 407365 US UNI RCMCRD
00643169410978LEAD 407345 US UNI RCMCRD
00643169410831LEAD 457453 US BI RCMCRD
00643169410824LEAD 457445 US BI RCMCRD

Trademark Results [CapSure Sense]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CAPSURE SENSE
CAPSURE SENSE
78122837 2851852 Live/Registered
MEDTRONIC INC.
2002-04-19
CAPSURE SENSE
CAPSURE SENSE
78065698 not registered Dead/Abandoned
MEDTRONIC, INC.
2001-05-25

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