Capsure® EPI

GUDID 00613994501776

LEAD 4965-35 US UNI EPI STERD 35CM

MEDTRONIC, INC.

Epicardial pacing lead
Primary Device ID00613994501776
NIH Device Record Key0192c0de-3afa-482c-bcf9-b360e83a0a34
Commercial Distribution StatusIn Commercial Distribution
Brand NameCapsure® EPI
Version Model Number4965-35
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

Device Dimensions

Length35 Centimeter
Length35 Centimeter
Length35 Centimeter
Length35 Centimeter
Length35 Centimeter
Length35 Centimeter
Length35 Centimeter
Length35 Centimeter
Length35 Centimeter
Length35 Centimeter
Length35 Centimeter
Length35 Centimeter
Length35 Centimeter
Length35 Centimeter
Length35 Centimeter
Length35 Centimeter
Length35 Centimeter
Length35 Centimeter
Length35 Centimeter
Length35 Centimeter
Length35 Centimeter
Length35 Centimeter
Length35 Centimeter
Length35 Centimeter
Length35 Centimeter
Length35 Centimeter
Length35 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994501776 [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 Date2014-09-23

On-Brand Devices [Capsure® EPI]

00613994501813LEAD 4965-50 US UNI EPI STEROID 50CM
00613994501776LEAD 4965-35 US UNI EPI STERD 35CM
00613994501745LEAD 4965-25 US UNI EPI STERD 25CM
00613994501721LEAD 4965-15 US UNI EPI STEROID 15CM
00613994492340LEAD 4968-60 US BIPOLAR EPICARDIAL 60CM
00613994492302LEAD 4968-35 US BIPOLAR EPICARDIAL 35CM
00613994492272LEAD 4968-25 US BIPOLAR EPICARDIAL 25CM
00681490116725LEAD 4968-35 BIP EPI US
00681490116503LEAD 4965-35 UNI EPI STEROID
00681490116336LEAD 4965-15 CAPSURE EPI PACING US

Trademark Results [Capsure]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CAPSURE
CAPSURE
97633688 not registered Live/Pending
Phoenix Brands, LLC
2022-10-15
CAPSURE
CAPSURE
97552678 not registered Live/Pending
Watershed Geosynthetics, LLC
2022-08-17
CAPSURE
CAPSURE
97361218 not registered Live/Pending
SILICON PRAIRIE HOLDINGS, INC,
2022-04-13
CAPSURE
CAPSURE
88400123 not registered Live/Pending
Soteria Group, Inc.
2019-04-24
CAPSURE
CAPSURE
88039533 5735536 Live/Registered
Hy-Vee, Inc.
2018-07-16
CAPSURE
CAPSURE
87897578 not registered Live/Pending
Guardian Medical LLC
2018-04-27
CAPSURE
CAPSURE
87659629 not registered Live/Pending
Orkin Expansion, Inc.
2017-10-25
CAPSURE
CAPSURE
87091281 5244337 Live/Registered
InfiniTek
2016-07-01
CAPSURE
CAPSURE
86222988 4648321 Live/Registered
ENVIRONMENTAL SAMPLING SUPPLY, INC.
2014-03-17
CAPSURE
CAPSURE
86222975 4648320 Live/Registered
ENVIRONMENTAL SAMPLING SUPPLY, INC.
2014-03-17
CAPSURE
CAPSURE
86222953 4648319 Live/Registered
ENVIRONMENTAL SAMPLING SUPPLY, INC.
2014-03-17
CAPSURE
CAPSURE
86191580 4796131 Live/Registered
C. R. Bard, Inc.
2014-02-12

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