Home GUDID 00763000368470 Aurora EV-ICD™ MRI SureScan™
Primary DI 00763000368470
Brand Aurora EV-ICD™ MRI SureScan™
Company MEDTRONIC, INC.
Model DVEA3E4
Device description ICD-VR DVEA3E4 EV-ICD EV4 US RW UPDATE
Published 2023-11-02
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
OTC false
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 00763000368470 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00763000368470 00763000368470 763000368470 0763000368470
GMDN Terms# Term, Definition table Term Definition Single-chamber implantable defibrillator An implantable pulse generator (IPG) with a cardiac rhythm recognition system, to analyse an electrocardiogram (ECG), intended to deliver an electrical impulse(s) to defibrillate the heart (restore normal rhythm) or slow a rapid heart rate, and typically to pace a slow heart rate. It is implanted in a pouch beneath the skin of the patient's chest or abdomen and has connected a lead(s) that are positioned inside or on one heart chamber (typically right ventricle) to monitor the ECG and to automatically deliver the electrical impulse. It has internal batteries that provide the energy for the discharges; it is commonly known as an automatic implantable cardioverter-defibrillator (AICD).
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 0 0
Regulatory Flags# DUNS number 006261481 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00763000001513 Primo MRI™ DR SureScan™ MEDTRONIC, INC. LWS 2018-06-02 00763000001551 Primo MRI™ VR SureScan™ MEDTRONIC, INC. LWS 2018-06-02 00643169410954 CapSure Sense MRI™ SureScan™ MEDTRONIC, INC. NVY 2017-10-26 00643169448957 CapSure Sense MRI™ SureScan™ MEDTRONIC, INC. NVY 2017-10-26 00763000059705 Evera MRI™ S DR SureScan® MEDTRONIC, INC. LWS 2017-10-21 00763000059491 Evera MRI™ XT DR SureScan® MEDTRONIC, INC. LWS 2017-10-20 00643169720374 Evera™ XT DR MEDTRONIC, INC. LWS 2017-09-15 00643169720497 Evera MRI™ XT DR SureScan® 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 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 00643169929876 Evera™ S VR 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 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 00643169708181 CapSureFix Novus MRI™ SureScan™ MEDTRONIC, INC. NVY 2016-12-26 00643169708198 CapSureFix Novus MRI™ SureScan™ MEDTRONIC, INC. NVY 2016-12-26
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