Home GUDID 00385480407298 Stat Profile
Primary DI 00385480407298
Brand Stat Profile
Company NOVA BIOMEDICAL CORPORATION
Model CCX
Catalog number 40729
Device description STAT PROFILE CRITICAL CARE EXPRESS CAPILLARY TUBE 115 uL WITH Na HEPARIN
Published 2016-09-20
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use 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 GHS ASSAY, CARBOXYHEMOGLOBIN GKR SYSTEM, HEMOGLOBIN, AUTOMATED JFP ELECTRODE, ION SPECIFIC, CALCIUM JGS ELECTRODE, ION SPECIFIC, SODIUM JIX CALIBRATOR, MULTI-ANALYTE MIXTURE JJS CONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED) 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 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 JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry 2 JJS Controls For Blood-Gases, (Assayed And Unassayed) 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 00385480407298 Primary GS1 0 00385489407299 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00385480407298 00385480407298 385480407298 0385480407298 00385489407299 00385489407299 385489407299 0385489407299
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.
Regulatory Flags# DUNS number 070617139 Device count 250 Lot or batch 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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