Home GUDID 00385480374132 STAT PROFILE
Primary DI 00385480374132
Brand STAT PROFILE
Company NOVA BIOMEDICAL CORPORATION
Model CCX CO OX
Catalog number 37413
Device description Stat Profile Critical Care Express 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 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 CIG DIAZO COLORIMETRY, BILIRUBIN GHS ASSAY, CARBOXYHEMOGLOBIN GKR SYSTEM, HEMOGLOBIN, AUTOMATED JFP ELECTRODE, ION SPECIFIC, CALCIUM JGS ELECTRODE, ION SPECIFIC, SODIUM JIT CALIBRATOR, SECONDARY JIX CALIBRATOR, MULTI-ANALYTE MIXTURE JJS CONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED) JJY Multi-analyte controls, all kinds (assayed) 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 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 CIG Diazo Colorimetry, Bilirubin Clinical Chemistry 2 GHS Assay, Carboxyhemoglobin Hematology 2 GKR System, Hemoglobin, Automated Hematology 2 JFP Electrode, Ion Specific, Calcium Clinical Chemistry 2 JGS Electrode, Ion Specific, Sodium Clinical Chemistry 2 JIT Calibrator, Secondary Clinical Chemistry 2 JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry 2 JJS Controls For Blood-Gases, (Assayed And Unassayed) Clinical Chemistry 1 JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry 1 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 10385480374139 Package GS1 1 In Commercial Distribution 00385480374132 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 10385480374139 10385480374139 00385480374132 00385480374132 385480374132 0385480374132
GMDN Terms# Term, Definition table Term Definition Co-oximetry analyser IVD, point-of-care A mains electricity (AC-powered) instrument, which may include internal rechargeable batteries, intended to be used by health professionals at the point-of-care, and often in the laboratory, for the quantitative in vitro measurement of oxygen saturation, haemoglobin derivatives and other calculated haemoximetry parameters in a whole blood specimen. Measurements may include haemoglobin oxygen saturation (SpO2), arterial oxygen saturation (SaO2), blood oxygen content/capacity, and haemoglobin forms such as oxyhaemoglobin (O2Hb), deoxyhaemoglobin (HHb) or reduced haemoglobin (RHb), carboxy-haemoglobin (COHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb), and total haemoglobin (totHb).
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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