DEVICE: K ELECTRODE, ISE MODULE (05999883586693)

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Device Identifier (DI) Information

K ELECTRODE, ISE MODULE
K+ Electrode
5202
Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
05999883586693
GS1
1
Clinical Chemistry Test Systems / Potassium test system. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
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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
Potassium (K+) electrode IVD An electrochemical sensor intended to be used to selectively measure electrical potential against a reference electrode to determine the concentration of potassium (K+) ions in a clinical specimen.
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FDA Product Code

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Product Code Product Code Name
CEM Electrode, Ion Specific, Potassium
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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
15999883586693 1 05999883586693 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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Customer Contact

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