CapSure Sense MRI™ SureScan™

GUDID 00643169410961

LEAD 457453 MRI US BI RCMCRD

MEDTRONIC, INC.

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Primary Device ID00643169410961
NIH Device Record Keya5e2ca74-c427-4c6d-ae8d-2d482fd9ae2a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCapSure Sense MRI™ SureScan™
Version Model Number457453
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Length53 Centimeter
Length53 Centimeter
Length53 Centimeter
Length53 Centimeter
Length53 Centimeter
Length53 Centimeter
Length53 Centimeter
Length53 Centimeter
Length53 Centimeter
Length53 Centimeter
Length53 Centimeter
Length53 Centimeter
Length53 Centimeter
Length53 Centimeter
Length53 Centimeter
Length53 Centimeter
Length53 Centimeter
Length53 Centimeter
Length53 Centimeter
Length53 Centimeter
Length53 Centimeter
Length53 Centimeter
Length53 Centimeter
Length53 Centimeter
Length53 Centimeter
Length53 Centimeter
Length53 Centimeter
Length53 Centimeter
Length53 Centimeter
Length53 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
GS100643169410961 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NVYPermanent defibrillator electrodes

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 Date2017-10-26

On-Brand Devices [CapSure Sense MRI™ SureScan™]

00643169448957LEAD 407458 MRI US BI RCMRCD
00643169448940LEAD 407452 MRI US BI RCMRCD
00643169448865LEAD 407458 MRI US BI MVC RCMRCD
00643169448858LEAD 407452 MRI US BI MVC RCMRCD
00643169410961LEAD 457453 MRI US BI RCMCRD
00643169410954LEAD 457445 MRI US BI RCMCRD
00643169410947LEAD 457453 MRI US BI RCMCRD MVC
00643169410916LEAD 457445 MRI US BI RCMCRD MVC

Trademark Results [CapSure Sense MRI]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CAPSURE SENSE MRI
CAPSURE SENSE MRI
86192657 5301778 Live/Registered
Medtronic, Inc.
2014-02-13
CAPSURE SENSE MRI
CAPSURE SENSE MRI
85172472 not registered Dead/Abandoned
Medtronic, Inc.
2010-11-09

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