DEVICE: EP-4™ (05414734219112)

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Device Identifier (DI) Information

EP-4™
H21911
H21911
ST. JUDE MEDICAL, INC.
05414734219112
GS1
1
Touch Computer Screen
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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
Cardiac electrophysiology stimulation system An assembly of devices programmed to deliver precisely timed electrical impulses to the heart, during spontaneous and paced rhythms, for diagnostic cardiac stimulation. It typically includes electrodes/leads applied to the heart and an external pulse generator (EPG). It may be used in asynchronous or synchronous mode, to deliver stimuli of variable strength, and for pacing in a wide range of cycle lengths (typically from 150 to 1500 ms). It is used for performing physiologic cardiac tests such as to determine the function of various components of the atrioventricular conduction, factors required for induction and termination of tachycardia, and to assess sinus node function.
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FDA Product Code

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Product Code Product Code Name
JOQ GENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE
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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
Storage Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between -20 and 60 Degrees Celsius
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Special Storage Condition, Specify: Keep Dry.
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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
April 22, 2016

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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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No
Yes
No
Yes
No CLOSE

Customer Contact

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