DEVICE: SmartLyte Electrolyte Analyzer (00811403019892)

Device Identifier (DI) Information

SmartLyte Electrolyte Analyzer
0-DD-SMARTLYTE
Not in Commercial Distribution

Diamond Diagnostics Inc.
00811403019892
GS1
June 05, 2023
1
947514303 *Terms of Use
SmartLyte® Na+, K+, Cl-, Ca++, Li+ Electrolyte Analyzer which tests serum, plasma, whole blood, pre-diluted urine samples, and QC materials. It is microprocessor-controlled analyzers which utilize ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in serum, plasma, whole blood, pre-diluted urine samples, and QC materials. Sodium, potassium, chloride and calcium are commonly measured for use in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders. Lithium is a drug used to treat mental illness.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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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?
56682 Ion-selective analyser IVD
An electrically-powered automated or semi-automated laboratory instrument intended to be used for the quantitative measurement of electrolytes and/or other ions in a clinical specimen using ion-specific membranes to selectively measure electrical potential against a reference electrode to determine the target ion concentration.
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FDA Product Code

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Product Code Product Code Name
CEM Electrode, Ion Specific, Potassium
CGZ Electrode, Ion-Specific, Chloride
JFP Electrode, Ion Specific, Calcium
JGS Electrode, Ion Specific, Sodium
JIH Flame Photometry, Lithium
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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FDA Premarket Submission

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Sterilization

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Storage and Handling

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Storage and Handling
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Clinically Relevant Size

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Device Record Status

319f766d-3d2e-4495-af46-19edbbb34dac
June 13, 2023
1
June 05, 2023
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Alternative and Additional Identifiers Additional Identifiers

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Unit of Use DI

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Direct Marking (DM)

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Production Identifier(s) in UDI

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Customer Contact

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