DEVICE: SJM™ (05414734501668)

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Device Identifier (DI) Information

SJM™
3630
3630
ST. JUDE MEDICAL, INC.
05414734501668
GS1
1
No description.
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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
Pacemaker programmer An external device that enables a user to interrogate, test, analyse and program, noninvasively, one or more of the operating parameters (the programs) of an implanted cardiac pacemaker. It is able to read stored parameters in the pacemaker, providing historic and/or current information regarding performance, and may be used to upload new software into the pacemaker. It is a dedicated device, typically with an electronic wand with a communication antenna, connected to a port of a personal computer (PC) using dedicated software to drive the electronics of the wand to communicate with the implanted pacemaker.
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FDA Product Code

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Product Code Product Code Name
NIK Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between -40 and 158 Degrees Fahrenheit
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -40 and 70 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between -40 and 70 Degrees Celsius
Handling Environment Temperature: between -40 and 158 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
January 19, 2015

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

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