DEVICE: Merlin™ (05414734503129)

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Device Identifier (DI) Information

Merlin™
PSA Cable Adapter
EX3170
ST. JUDE MEDICAL, INC.
05414734503129
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

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

GMDN Preferred Term Name GMDN Definition
External pacemaker analyser An electronic instrument designed to test an external pacemaker to ensure compliance with performance specifications. The device connects to the output of the pacemaker to test any or all of the pulse generator's parameters including pulse duration, pulse amplitude, pulse rate, and sensing threshold. The device may be used to test the function of an external pacemaker periodically, after repair, or for training purposes.
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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

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Storage and Handling
Handling Environment Temperature: between -10 and 50 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 14 and 122 Degrees Fahrenheit
Storage Environment Temperature: between 14 and 122 Degrees Fahrenheit
Storage Environment Temperature: between -10 and 50 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Length: 10 Inch
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Device Status

In Commercial Distribution
September 30, 2014

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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
Yes
No CLOSE

Customer Contact

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