DEVICE: SJM CONFIRM™ (05414734502696)

Device Identifier (DI) Information

SJM CONFIRM™
DM2100A
In Commercial Distribution
DM2100A
ST. JUDE MEDICAL, INC.
05414734502696
GS1

1
790268031 *Terms of Use
External Patient Activator
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
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 patient programmer A hand-held, battery-powered device designed to be operated by a patient to non-invasively change the settings (e.g., turn on/off) of their implantable cardiac monitor (ICM), and typically also extract data from the implant; 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. This is a home-use device.
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FDA Product Code

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

FDA Premarket Submission Number [?] Supplement Number [?]
K101968 000
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Sterilization

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

[?]
Storage and Handling
Handling Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between -4 and 131 Degrees Fahrenheit
Storage Environment Temperature: between -4 and 131 Degrees Fahrenheit
Handling Environment Temperature: between -20 and 55 Degrees Celsius
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 55 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

2be00df7-1e5b-4e52-81db-2e7e213c8493
July 06, 2018
3
April 10, 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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