DEVICE: Blood Gas and Chemistry Analyzer (06944413801875)

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Device Identifier (DI) Information

Blood Gas and Chemistry Analyzer
i15

Edan Instruments, Inc.
06944413801875
GS1
1
No description.
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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
Metabolic profile clinical chemistry analyser IVD, stationary, semi-automated A stationary mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro measurement of multiple clinical chemistry analytes to generate a metabolic profile. Analytes may include pH, blood gas parameters [e.g., partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2)], electrolytes [e.g., sodium (Na2+), potassium (K+), chloride (Cl-)], glucose, urea, creatinine and sometimes haemoximetry parameters [e.g., carboxy-haemoglobin (COHb), methaemoglobin (MetHb), total haemoglobin (totHb), hematrocrit (Hct)]. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.
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FDA Product Code

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Product Code Product Code Name
GLK Control, Hematocrit
JJS Controls For Blood-Gases, (Assayed And Unassayed)
JIX Calibrator, Multi-Analyte Mixture
GKF Instrument, Hematocrit, Automated
JFP Electrode, Ion Specific, Calcium
CGZ Electrode, Ion-Specific, Chloride
CEM Electrode, Ion Specific, Potassium
JGS Electrode, Ion Specific, Sodium
CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
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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
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Clinically Relevant Size

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Size Type Text
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Device Status

In Commercial Distribution
September 01, 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
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Secondary DI

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Issuing Agency [?] Secondary DI Number
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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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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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