Home GUDID 00385480420174 STAT PROFILE
Primary DI 00385480420174
Brand STAT PROFILE
Company NOVA BIOMEDICAL CORPORATION
Model PHOX ULTRA CO OX
Catalog number 42017
Device description Remanufactured Stat Profile pHOx Ultra CO-Oximeter 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 BXX CALIBRATOR, PRESSURE, GAS CDS ELECTRODE, ION SPECIFIC, UREA NITROGEN CEM ELECTRODE, ION SPECIFIC, POTASSIUM CFA ELECTRODE, ION SPECIFIC, MAGNESIUM CGA GLUCOSE OXIDASE, GLUCOSE CGL ELECTRODE, ION BASED, ENZYMATIC, CREATININE CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE CHL ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH GGZ OXYHEMOGLOBIN GHS ASSAY, CARBOXYHEMOGLOBIN GJC ASSAY, SULFHEMOGLOBIN GKK CYANOMETHEMOGLOBIN GLY OXIMETER TO MEASURE HEMOGLOBIN JFP ELECTRODE, ION SPECIFIC, CALCIUM JGS ELECTRODE, ION SPECIFIC, SODIUM JIX CALIBRATOR, MULTI-ANALYTE MIXTURE JJB AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.) NGD TEST, LACTIC ACID, OVER THE COUNTER
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class BXX Calibrator, Pressure, Gas Anesthesiology 1 CDS Electrode, Ion Specific, Urea Nitrogen Clinical Chemistry 2 CEM Electrode, Ion Specific, Potassium Clinical Chemistry 2 CFA Electrode, Ion Specific, Magnesium Clinical Chemistry 1 CGA Glucose Oxidase, Glucose Clinical Chemistry 2 CGL Electrode, Ion Based, Enzymatic, Creatinine Clinical Chemistry 2 CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry 2 CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph Clinical Chemistry 2 GGZ Oxyhemoglobin Hematology 2 GHS Assay, Carboxyhemoglobin Hematology 2 GJC Assay, Sulfhemoglobin Hematology 2 GKK Cyanomethemoglobin Hematology 2 GLY Oximeter To Measure Hemoglobin Hematology 2 JFP Electrode, Ion Specific, Calcium Clinical Chemistry 2 JGS Electrode, Ion Specific, Sodium Clinical Chemistry 2 JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry 2 JJB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) Clinical Chemistry 1 NGD Test, Lactic Acid, Over The Counter Clinical Chemistry 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10385480420171 Package GS1 1 In Commercial Distribution 00385480420174 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 10385480420171 10385480420171 00385480420174 00385480420174 385480420174 0385480420174
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 20 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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