Home GUDID 05415067047809 Assert-IQ™
Primary DI 05415067047809
Brand Assert-IQ™
Company ST. JUDE MEDICAL, INC.
Model DM5500
Catalog number DM5500
Device description EL+ Insertable Cardiac Monitor
Published 2023-06-13
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name MXC Recorder, event, implantable cardiac, (without arrhythmia detection)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05415067047809 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05415067047809 05415067047809 5415067047809
GMDN Terms# Term, Definition table Term Definition Implantable cardiac monitor A hermetically-sealed, electrically-powered device [an implantable cardiac monitor (ICM)] intended to be implanted to monitor, record, and store electrocardiographic signals to help diagnose and monitor cardiac arrhythmias and/or acute coronary syndrome (ACS) changes; it may have a vibratory alarm function and the data can be telemetrically transmitted to an external device for alarming the patient and/or remote data transmission. It is used for a patient who experiences unexplained cardiac-related symptoms and/or is at risk for cardiac arrhythmias and/or ACS events.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Keep dry, keep away from sunlight. Storage excursions permitted from 59°- 86° F (15°- 30°C).
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 05415067047311 Merlin.net™ ST. JUDE MEDICAL, INC. MXC 2023-06-16 05415067047793 Assert-IQ™ ST. JUDE MEDICAL, INC. MXC 2023-06-13 05415067047816 Assert-IQ™ ST. JUDE MEDICAL, INC. MXC 2023-06-13 05415067040046 Jot Dx™ ST. JUDE MEDICAL, INC. MXC 2021-07-09 05415067034304 Confirm Rx™ ST. JUDE MEDICAL, INC. MXC 2020-12-09 05415067027320 Confirm Rx™ ST. JUDE MEDICAL, INC. MXC 2017-11-13 05415067027399 myMerlin™ ST. JUDE MEDICAL, INC. MXC 2017-11-13 05415067027405 myMerlin™ ST. JUDE MEDICAL, INC. MXC 2017-11-13 05414734502696 SJM CONFIRM™ ST. JUDE MEDICAL, INC. MXC 2017-04-10 05414734502573 SJM CONFIRM™ ST. JUDE MEDICAL, INC. MXC 2017-02-03 05414734502597 SJM CONFIRM™ ST. JUDE MEDICAL, INC. MXC 2017-02-03
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