Home GUDID 05414734510059 SJM MRI Activator™
Primary DI 05414734510059
Brand SJM MRI Activator™
Company ST. JUDE MEDICAL, INC.
Model EX4001
Catalog number EX4001
Device description Handheld Device
Published 2017-11-03
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true Product Codes# Code, Name table Code Name LWP Implantable pulse generator, pacemaker (non-CRT)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LWP Implantable Pulse Generator, Pacemaker (Non-Crt) Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05414734510059 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05414734510059 05414734510059 5414734510059
GMDN Terms# Term, Definition table Term Definition Implantable cardiac monitor programmer/transmitter/alarm A hand-held, electrically-powered device designed to be operated by a clinician or patient to non-invasively change the settings (e.g., turn on/off) of an implantable cardiac monitor (ICM), and/or extract data from the implant, and/or provide an alarm function; it is not intended to communicate with a therapeutic cardiac implant. It includes a radio-frequency transmitter/receiver and may be intended to operate independently or in conjunction with a personal computer (PC)/tablet using dedicated software. It may be used in the home or healthcare facility.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Humidity 5 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature -20 Degrees Celsius 55 Degrees Celsius Storage Environment Temperature -4 Degrees Fahrenheit 131 Degrees Fahrenheit
Regulatory Flags# DUNS number 790268031 Device count 1 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 05415067055507 Zenex MRI™ ST. JUDE MEDICAL, INC. LWP 2026-01-22 05415067055514 Zenex MRI™ ST. JUDE MEDICAL, INC. LWP 2026-01-22 05415067049575 Merlin™ ST. JUDE MEDICAL, INC. LWP 2025-06-25 05415067050045 Neutrino™ ST. JUDE MEDICAL, INC. LWP 2025-02-11 05415067050052 Gallant™ ST. JUDE MEDICAL, INC. LWP 2025-02-11 05415067050076 Neutrino™ ST. JUDE MEDICAL, INC. LWP 2025-02-11 05415067050090 Gallant™ ST. JUDE MEDICAL, INC. LWP 2025-02-11 05415067050106 Entrant™ ST. JUDE MEDICAL, INC. LWP 2025-02-11 05415067050120 Entrant™ ST. JUDE MEDICAL, INC. LWP 2025-02-11 05415067034809 Merlin@home™ ST. JUDE MEDICAL, INC. LWP 2024-11-13 00763000181116 NA MEDTRONIC, INC. LWP 2024-08-30 00763000181130 NA MEDTRONIC, INC. LWP 2024-08-30 20763000181110 NA MEDTRONIC, INC. LWP 2024-08-30 20763000181134 NA MEDTRONIC, INC. LWP 2024-08-30 05415067040404 NA ST. JUDE MEDICAL, INC. LWP 2023-01-09 05415067031174 Merlin™ ST. JUDE MEDICAL, INC. LWP 2022-08-29 05415067037121 Merlin™ ST. JUDE MEDICAL, INC. LWP 2022-08-29 00763000181208 NA MEDTRONIC, INC. LWP 2021-05-22 00763000181215 NA MEDTRONIC, INC. LWP 2021-05-14 00763000316709 Azure™ XT SR MRI SureScan™ MEDTRONIC, INC. LWP 2021-02-25 00763000316693 Azure™ S DR MRI SureScan™ MEDTRONIC, INC. LWP 2021-01-08 00763000316716 Azure™ S SR MRI SureScan™ MEDTRONIC, INC. LWP 2021-01-08 00763000316846 Azure™ XT DR MRI SureScan™ MEDTRONIC, INC. LWP 2021-01-08 00763000316723 Adapta™ MEDTRONIC, INC. LWP 2020-11-28 00763000316730 Adapta™ MEDTRONIC, INC. LWP 2020-11-28 00763000316747 Adapta™ S MEDTRONIC, INC. LWP 2020-11-28 00763000316761 Adapta™ MEDTRONIC, INC. LWP 2020-11-28 00763000316778 Adapta™ MEDTRONIC, INC. LWP 2020-11-28 00763000316785 Adapta™ MEDTRONIC, INC. LWP 2020-11-28 00763000316792 Adapta™ MEDTRONIC, INC. LWP 2020-11-28
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