DEVICE: SJM CONFIRM™ (05414734502597)

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Device Identifier (DI) Information

SJM CONFIRM™
DM2100
DM2100
ST. JUDE MEDICAL, INC.
05414734502597
GS1
1
Implantable Cardiac Monitor
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Device Characteristics

MR Conditional
No
No
Yes
Yes
No
Yes
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Implantable cardiac monitor A hermetically-sealed, battery-powered device with an integrated electrode [an implantable cardiac monitor (ICM)] implanted beneath the skin to monitor, record, and store electrocardiographic signals to help diagnose and monitor cardiac arrhythmias; this data can be telemetrically transmitted via an externally placed patient activator and monitored remotely by a healthcare professional using a cardiac pacemaker programmer. The device is used for a patient who experiences unexplained symptoms such as, dizziness, palpitations, chest pain, syncope and shortness of breath, as well as patients who are at risk for cardiac arrhythmias.
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FDA Product Code

[?]
Product Code Product Code Name
MXC RECORDER,EVENT,IMPLANTABLE CARDIAC,(WITHOUT ARRHYTHMIA DETECTION)
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 14 and 131 Degrees Fahrenheit
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 14 and 131 Degrees Fahrenheit
Handling Environment Temperature: between -10 and 55 Degrees Celsius
Storage Environment Temperature: between -10 and 55 Degrees Celsius
Handling Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify: Store the device in a clean area.
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
February 03, 2017

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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(855)478-5833
customerservice@sjm.com
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