Transvene®-CS/SVC

GUDID 00613994492432

LEAD 6937A-65 US CS SVC UNI

MEDTRONIC, INC.

Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead
Primary Device ID00613994492432
NIH Device Record Keyc900b389-9a52-4fc9-ac18-abf1ae9abf19
Commercial Distribution Discontinuation2018-06-21
Commercial Distribution StatusNot in Commercial Distribution
Brand NameTransvene®-CS/SVC
Version Model Number6937A-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 Productfalse
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

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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994492432 [Primary]

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 Date2018-06-26
Device Publish Date2014-09-23

On-Brand Devices [Transvene®-CS/SVC]

00613994492432LEAD 6937A-65 US CS SVC UNI
00613994492418LEAD 6937A-58 US CS SVC UNI
00613994492401LEAD 6937A-52 US CS SVC UNI
00613994492388LEAD 6937A-35 US CS SVC UNI
00613994492364LEAD 6937A-100 US CS SVC UNI
00643169536029LEAD 6937A-52 CS SVC UNI US
00643169536012LEAD 6937A-35 CS SVC UNI US
00643169536005LEAD 6937A-100 CS SVC UNI US
00643169535992LEAD 6937A-65 CS SVC UNI US
00643169535985LEAD 6937A-58 CS SVC UNI US

Trademark Results [Transvene]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TRANSVENE
TRANSVENE
74216530 1756098 Dead/Cancelled
Medtronic, Inc.
1991-10-28

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