CapSure® VDD-2

GUDID 00681490122733

LEAD 5038L-65 QUAD SNGL-P A/V 15.5CM US

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 ID00681490122733
NIH Device Record Keyc5e58142-f3c1-4969-a86c-93b6604a68cf
Commercial Distribution StatusIn Commercial Distribution
Brand NameCapSure® VDD-2
Version Model Number5038L-65
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

Length65 Centimeter
Length65 Centimeter
Length65 Centimeter
Length65 Centimeter
Length65 Centimeter
Length65 Centimeter
Length65 Centimeter
Length65 Centimeter
Length65 Centimeter
Length65 Centimeter
Length65 Centimeter
Length65 Centimeter
Length65 Centimeter
Length65 Centimeter
Length65 Centimeter
Length65 Centimeter
Length65 Centimeter
Length65 Centimeter
Length65 Centimeter
Length65 Centimeter
Length65 Centimeter
Length65 Centimeter
Length65 Centimeter
Length65 Centimeter
Length65 Centimeter
Length65 Centimeter
Length65 Centimeter
Length65 Centimeter
Length65 Centimeter
Length65 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
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
GS100681490122733 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NVNDrug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker 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 Date2014-09-23

On-Brand Devices [CapSure® VDD-2]

00613994250155LEAD-5038S-52,US FPA 52CM PASS QUAD SIL
00613994250148LEAD 5038S-58 US FPA PASS QUAD SILIC
00643169325715LEAD 5038S-58 USA NO SILACURE
00643169325708LEAD 5038S-52 USA NO SILACURE
00643169325692LEAD 5038L-65 USA NO SILACURE
00643169325685LEAD 5038-65 USA NO SILACURE
00643169325678LEAD 5038-58 USA NO SILACURE
00681490122931LEAD 5038S-58 QUAD SNGL-P A/V 11.5CM US
00681490122832LEAD 5038S-52 QUAD SNGL-P A/V 11.5CM US
00681490122733LEAD 5038L-65 QUAD SNGL-P A/V 15.5CM US
00885074201573LEAD 5038-65 CAPSURE VDD2 PACING US
00885074201566LEAD 5038-58 CAPSURE VDD2 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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