Home GUDID 00385480347174 STAT PROFILE
Primary DI 00385480347174
Brand STAT PROFILE
Company NOVA BIOMEDICAL CORPORATION
Model PHOX PLUS L
Catalog number 34717
Device description Remanufactured Stat Profile pHOx Plus L Analyzer
Published 2016-09-20
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name CEM ELECTRODE, ION SPECIFIC, POTASSIUM CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE CHL ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH GJS TEST, TIME, PROTHROMBIN GKR SYSTEM, HEMOGLOBIN, AUTOMATED JFP ELECTRODE, ION SPECIFIC, CALCIUM JIX CALIBRATOR, MULTI-ANALYTE MIXTURE JKS Spectral absorb. Curve, oxyhemoglobin, carboxyhemoglobin, carbon-monoxide JPI DEVICE, HEMATOCRIT MEASURING JPK MIXTURE, HEMATOLOGY QUALITY CONTROL KHP ACID, LACTIC, ENZYMATIC METHOD
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class CEM Electrode, Ion Specific, Potassium Clinical Chemistry 2 CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry 2 CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph Clinical Chemistry 2 GJS Test, Time, Prothrombin Hematology 2 GKR System, Hemoglobin, Automated Hematology 2 JFP Electrode, Ion Specific, Calcium Clinical Chemistry 2 JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry 2 JKS Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide Clinical Toxicology 1 JPI Device, Hematocrit Measuring Hematology 2 JPK Mixture, Hematology Quality Control Hematology 2 KHP Acid, Lactic, Enzymatic Method Clinical Chemistry 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10385480347171 Package GS1 1 In Commercial Distribution 00385480347174 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10385480347171 10385480347171 00385480347174 00385480347174 385480347174 0385480347174
GMDN Terms# Term, Definition table Term Definition Metabolic profile clinical chemistry analyser IVD, portable, semi-automated A portable mains electricity (AC-powered) laboratory instrument, which may include internal rechargeable batteries, 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., pO2, pCO2), electrolytes [e.g., sodium (Na2+), potassium (K+), chloride (Cl-)], glucose, urea, creatinine and sometimes in addition haemoximetry parameters [e.g., carboxy-haemoglobin (COHb), methaemoglobin (MetHb), total haemoglobin (totHb), hematrocrit (Hct)]. It operates with reduced technician involvement and automation of some procedural steps.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 15 Degrees Celsius 30 Degrees Celsius Special Storage Condition, Specify 0 0 0 ft to 15000 ft Special Storage Condition, Specify 0 0 Without Condensation Storage Environment Humidity 0 Percent (%) Relative Humidity 85 Percent (%) Relative Humidity Storage Environment Temperature 15 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 070617139 Device count 1 Serial number true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# 
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