DEVICE: NA ELECTRODE, ISE MODULE (05999883586686)

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Device Identifier (DI) Information

NA ELECTRODE, ISE MODULE
NA+ Electrode
5201
Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
05999883586686
GS1
1
Clinical Chemistry Test Systems / Sodium test system. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
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Device Characteristics

Labeling does not contain MRI Safety Information
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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
Sodium (Na+) electrode IVD An electrochemical sensor intended to be used to selectively measure electrical potential against a reference electrode to determine the concentration of sodium (Na+) ions in a clinical specimen.
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FDA Product Code

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Product Code Product Code Name
JGS Electrode, Ion Specific, Sodium
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Sterilization

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

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Storage and Handling
Storage Environment Temperature: between 4 and 25 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Height: 60 Millimeter
Depth: 40 Millimeter
Width: 90 Millimeter
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Device Status

In Commercial Distribution
October 06, 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
15999883586686 1 05999883586686 In Commercial Distribution box
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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
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None
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Production Identifier(s) in UDI

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Yes
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No CLOSE

Customer Contact

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+1207-450-4228
John.Roche@diatron.com
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