Home GUDID 05414734502573 SJM CONFIRM™
Primary DI 05414734502573
Brand SJM CONFIRM™
Company ST. JUDE MEDICAL, INC.
Model DM2102
Catalog number DM2102
Device description Implantable Cardiac Monitor with AF detection
Published 2017-02-03
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 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 05414734502573 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05414734502573 05414734502573 5414734502573
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 Handling Environment Humidity 5 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Handling Environment Temperature -10 Degrees Celsius 55 Degrees Celsius Handling Environment Temperature 14 Degrees Fahrenheit 131 Degrees Fahrenheit Special Storage Condition, Specify 0 0 Store the device in a clean area. Storage Environment Humidity 5 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature -10 Degrees Celsius 55 Degrees Celsius Storage Environment Temperature 14 Degrees Fahrenheit 131 Degrees Fahrenheit
Regulatory Flags# DUNS number 790268031 Device count 1 Kit 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 05415067047311 Merlin.net™ ST. JUDE MEDICAL, INC. MXC 2023-06-16 05415067047793 Assert-IQ™ ST. JUDE MEDICAL, INC. MXC 2023-06-13 05415067047809 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 05414734502597 SJM CONFIRM™ ST. JUDE MEDICAL, INC. MXC 2017-02-03
sjm.com