Home GUDID 05415067040404 NA
Primary DI 05415067040404
Brand NA
Company ST. JUDE MEDICAL, INC.
Model EX2000
Catalog number EX2000
Device description MerlinAtHome Software
Published 2023-01-09
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name DXY implantable pacemaker Pulse-generator LWO Pulse-generator, single chamber, sensor driven, implantable LWP Implantable pulse generator, pacemaker (non-CRT) LWS Implantable cardioverter defibrillator (non-CRT) NIK Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) NKE Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) OSR Pacemaker/icd/crt non-implanted components
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DXY Implantable Pacemaker Pulse-Generator Cardiovascular 3 LWO Pulse-Generator, Single Chamber, Sensor Driven, Implantable Unknown 3 LWP Implantable Pulse Generator, Pacemaker (Non-Crt) Unknown 3 LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown 3 NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown 3 NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown 3 OSR Pacemaker/Icd/Crt Non-Implanted Components Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05415067040404 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05415067040404 05415067040404 5415067040404
GMDN Terms# Term, Definition table Term Definition Transtelephonic implantable pacemaker analysis system An assembly of devices designed to analyse the performance of an implanted pacemaker based on electrocardiographic measurements that can be monitored transtelephonically. It typically includes a computer-based pacemaker analyser, a 12-lead electrocardiograph (ECG), and a transtelephonic receiver and/or transmitter. It provides data taken directly from the patient (e.g., ECG electrodes are applied to the patient and a test magnet is placed over the pacemaker to activate it) or a pacemaker programmer. Signals are sent to the receiver where pacemaker function information is displayed. This system may also include a database that collects and stores patient data.
Regulatory Flags# DUNS number 149818952 Device count 1 Lot or batch true Manufacturing 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 00763000180027 Sprint Quattro Secure S™ MEDTRONIC, INC. LWS 2024-11-04 00763000180041 Sprint Quattro Secure S MRI™ SureScan™ MEDTRONIC, INC. LWS 2024-11-04 00763000180256 Sprint Quattro Secure MRI™ SureScan™ MEDTRONIC, INC. LWS 2024-11-04 00763000181116 NA MEDTRONIC, INC. LWP 2024-08-30 00763000181130 NA MEDTRONIC, INC. LWP 2024-08-30 00763000181185 NA MEDTRONIC, INC. OSR 2023-01-30 00763000181215 NA MEDTRONIC, INC. DXY 2021-05-14 00763000060015 Evera MRI™ S DR SureScan™ MEDTRONIC, INC. LWS 2020-09-04 00763000060107 Visia AF MRI™ S VR SureScan™ MEDTRONIC, INC. LWS 2020-09-04 00763000178376 Cobalt™ DR MRI SureScan™ MEDTRONIC, INC. LWS 2020-06-08 00763000178413 Crome™ DR MRI SureScan™ MEDTRONIC, INC. LWS 2020-06-08 00763000178437 Crome™ DR MRI SureScan™ MEDTRONIC, INC. LWS 2020-06-08 00763000178512 Cobalt™ VR MRI SureScan™ MEDTRONIC, INC. LWS 2020-06-08 00763000178536 Crome™ VR MRI SureScan™ MEDTRONIC, INC. LWS 2020-06-08 00763000178550 Crome™ VR MRI SureScan™ MEDTRONIC, INC. LWS 2020-06-08 00643169552043 MyCareLink™ MEDTRONIC, INC. OSR 2019-10-13 00763000033194 MyCareLink™ MEDTRONIC, INC. OSR 2019-10-13 00763000033217 MyCareLink™ MEDTRONIC, INC. OSR 2019-10-13 00763000059477 NA MEDTRONIC, INC. DXY 2018-12-28 00763000060428 NA MEDTRONIC, INC. NKE 2018-12-16 00643169634626 Azure™ XT SR MRI SureScan™ MEDTRONIC, INC. LWP 2017-12-02 00643169725386 MyCareLink™ MEDTRONIC, INC. OSR 2017-11-16 00643169871953 Azure™ XT SR MRI SureScan™ MEDTRONIC, INC. LWP 2017-11-02 00763000059545 Viva™ XT CRT-D MEDTRONIC, INC. NIK 2017-10-21 00763000059569 Evera™ XT DR MEDTRONIC, INC. LWS 2017-10-21 00763000059705 Evera MRI™ S DR SureScan® MEDTRONIC, INC. LWS 2017-10-21 00763000059507 Visia AF MRI™ VR SureScan™ MEDTRONIC, INC. LWS 2017-10-20 00643169708686 Adapta™ L MEDTRONIC, INC. LWP 2017-10-20 00643169709065 Sensia™ MEDTRONIC, INC. LWP 2017-10-20 00643169709072 Versa™ MEDTRONIC, INC. LWP 2017-10-20
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