DEVICE: EnSite NavX Surface Electrode Kit (05414734210003)

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Device Identifier (DI) Information

EnSite NavX Surface Electrode Kit
EN0010-100003331
100003331
ST. JUDE MEDICAL, INC.
05414734210003
GS1
1
Surface Electrode Kit
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
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 mapping system reference patch A component of a cardiac mapping system that is an adhesive device placed on the surface of a patient's body, typically the chest and/or back, to provide a fixed reference point for the tip of an internal, non-fluoroscopic catheter during an electrophysiological and electromechanical real-time mapping of the heart. It may be sensor-containing or have a sensor attached to it, and is used to compensate for patient movement during the procedure. It is typically used with a cardiac mapping system computer to assist in the location and navigation of the catheter tip, and to provide electrocardiogram information. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
DQK COMPUTER, DIAGNOSTIC, PROGRAMMABLE
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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 Temperature: between -10 and 40 Degrees Celsius
Storage Environment Temperature: between -10 and 40 Degrees Celsius
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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
May 31, 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
15414734210000 5 05414734210003 In Commercial Distribution
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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
Yes
Yes
No CLOSE

Customer Contact

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