DEVICE: Merlin™ (05414734503136)
Device Identifier (DI) Information
Merlin™
EX3180
In Commercial Distribution
EX3180
ST. JUDE MEDICAL, INC.
EX3180
In Commercial Distribution
EX3180
ST. JUDE MEDICAL, INC.
Adapter Medtronic Patient Cable Model 2292
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
No | |
Yes | |
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No | |
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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? |
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31700 | 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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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NIK | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -10 and 50 Degrees Celsius |
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Handling Environment Temperature: between 14 and 122 Degrees Fahrenheit |
Handling Environment Temperature: between -10 and 50 Degrees Celsius |
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Storage Environment Temperature: between 14 and 122 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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Length: 10 Inch |
Device Record Status
155aefa7-7550-4e1c-b416-5edb5f418417
October 05, 2023
6
September 30, 2014
October 05, 2023
6
September 30, 2014
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 |
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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