Home GUDID 05414734502146 Durata™
Primary DI 05414734502146
Brand Durata™
Company ST. JUDE MEDICAL, INC.
Model 7122
Catalog number 7122
Device description Defibrillation Lead
Published 2017-02-02
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name LWS Implantable cardioverter defibrillator (non-CRT) NVY Permanent defibrillator electrodes
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown 3 NVY Permanent Defibrillator Electrodes Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05414734502146 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05414734502146 05414734502146 5414734502146
GMDN Terms# Term, Definition table Term Definition Endocardial defibrillation lead A sterile, implantable flexible wire with an electrode, insulated with non-conductive material except at its ends, intended to function as an electrical conductor to transmit defibrillation impulses from an implanted cardioverter-defibrillator (ICD) [automatic implantable cardioverter-defibrillator (AICD)] to the endocardium of the right ventricle. It may also be intended to transmit pacing impulses from a cardiac resynchronization therapy (CRT) pulse generator, AICD, or other pacing device. It is typically impregnated with a steroid (e.g., dexamethasone) intended to elute into the tissues to reduce inflammation.
Device Sizes# Type, Value, Unit table Type Value Unit Catheter Gauge 7 French Length 60 Centimeter
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature -5 Degrees Celsius 50 Degrees Celsius Handling Environment Temperature 23 Degrees Fahrenheit 122 Degrees Fahrenheit Special Storage Condition, Specify 0 0 Storage excursions permitted from 15-30°C (59-86°F). For Trans/Handling excursions allowed from -5-50°C (23-122°F) Special Storage Condition, Specify 0 0 Yes Storage Environment Temperature -5 Degrees Celsius 50 Degrees Celsius Storage Environment Temperature 20 Degrees Celsius 25 Degrees Celsius Storage Environment Temperature 23 Degrees Fahrenheit 122 Degrees Fahrenheit Storage Environment Temperature 68 Degrees Fahrenheit 77 Degrees Fahrenheit
Regulatory Flags# DUNS number 790268031 Device count 1 Combination product true Serial number true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00643169410954 CapSure Sense MRI™ SureScan™ MEDTRONIC, INC. NVY 2017-10-26 00643169448957 CapSure Sense MRI™ SureScan™ MEDTRONIC, INC. NVY 2017-10-26 00643169988651 Visia AF MRI™ S VR SureScan™ MEDTRONIC, INC. LWS 2017-09-25 00643169720374 Evera™ XT DR MEDTRONIC, INC. LWS 2017-09-15 00643169720527 Evera MRI™ S DR SureScan® MEDTRONIC, INC. LWS 2017-09-15 00643169720558 Evera MRI™ XT VR SureScan® MEDTRONIC, INC. LWS 2017-09-15 00643169720626 Visia AF™ VR MEDTRONIC, INC. LWS 2017-09-15 00643169720794 Visia AF MRI™ VR SureScan™ MEDTRONIC, INC. LWS 2017-09-15 00643169837829 Visa AF MRI™ S VR SureScan™ MEDTRONIC, INC. LWS 2017-09-15 00643169858305 Sprint Quattro™ MRI SureScan™ MEDTRONIC, INC. LWS 2017-06-11 00643169858329 Sprint Quattro™ MRI SureScan™ MEDTRONIC, INC. NVY 2017-06-11 00643169453180 CapSureFix™ Novus MEDTRONIC, INC. NVY 2017-06-02 00643169633735 CapSureFix Novus MRI™ SureScan® MEDTRONIC, INC. NVY 2017-06-02 00643169633742 CapSureFix Novus MRI™ SureScan® MEDTRONIC, INC. NVY 2017-06-02 00643169633766 CapSureFix Novus MRI™ SureScan® MEDTRONIC, INC. NVY 2017-06-02 00643169633773 CapSureFix Novus MRI™ SureScan® MEDTRONIC, INC. NVY 2017-06-02 00643169633780 CapSureFix Novus MRI™ SureScan® MEDTRONIC, INC. NVY 2017-06-02 00643169929258 Evera MRI™ S DR SureScan™ MEDTRONIC, INC. LWS 2017-05-22 00643169929265 Evera MRI™ S DR SureScan® MEDTRONIC, INC. LWS 2017-05-22 00643169929944 Visia AF MRI™ S VR SureScan™ MEDTRONIC, INC. LWS 2017-05-22 00643169857674 SelectSecure™ MRI SureScan™ MEDTRONIC, INC. NVY 2017-05-21 00643169857681 SelectSecure™ MRI SureScan™ MEDTRONIC, INC. NVY 2017-05-21 00643169857698 SelectSecure™ MRI SureScan™ MEDTRONIC, INC. NVY 2017-05-21 00643169929197 Evera MRI™ XT DR SureScan™ MEDTRONIC, INC. LWS 2017-05-14 00643169929760 Visia AF™ VR MEDTRONIC, INC. LWS 2017-05-14 00643169929913 Visia AF MRI™ VR SureScan™ MEDTRONIC, INC. LWS 2017-05-12 00643169410916 CapSure Sense MRI™ SureScan™ MEDTRONIC, INC. NVY 2017-02-05 00643169448858 CapSure Sense MRI™ SureScan™ MEDTRONIC, INC. NVY 2017-02-05 00643169448865 CapSure Sense MRI™ SureScan™ MEDTRONIC, INC. NVY 2017-02-05 00643169708174 CapSureFix Novus MRI™ SureScan™ MEDTRONIC, INC. NVY 2016-12-26
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