DEVICE: SJM CONFIRM™ (05414734502573)
Device Identifier (DI) Information
SJM CONFIRM™
DM2102
In Commercial Distribution
DM2102
ST. JUDE MEDICAL, INC.
DM2102
In Commercial Distribution
DM2102
ST. JUDE MEDICAL, INC.
Implantable Cardiac Monitor with AF detection
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
47804 | 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.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MXC | RECORDER,EVENT,IMPLANTABLE CARDIAC,(WITHOUT ARRHYTHMIA DETECTION) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K133481 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store the device in a clean area. |
Storage Environment Temperature: between 14 and 131 Degrees Fahrenheit |
Handling Environment Temperature: between -10 and 55 Degrees Celsius |
Handling Environment Temperature: between 14 and 131 Degrees Fahrenheit |
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity |
Handling Environment Humidity: between 5 and 95 Percent (%) Relative Humidity |
Storage Environment Temperature: between -10 and 55 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
9cfe2d8c-0d10-4dc3-80b7-a50b3a5bf040
September 18, 2023
5
February 03, 2017
September 18, 2023
5
February 03, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(855)478-5833
customerservice@sjm.com
customerservice@sjm.com