Home GUDID 00385480115339 STAT PROFILE
Primary DI 00385480115339
Brand STAT PROFILE
Company NOVA BIOMEDICAL CORPORATION
Model ULTRA
Catalog number 11533
Device description STAT PROFILE/M/ULTRA CAPILLARY TUBE KIT: 250uL WITH Li HEPARIN
Published 2016-09-16
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 CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE CHL ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH JFP ELECTRODE, ION SPECIFIC, CALCIUM JGS ELECTRODE, ION SPECIFIC, SODIUM JIX CALIBRATOR, MULTI-ANALYTE MIXTURE JJY Multi-analyte controls, all kinds (assayed) JKS Spectral absorb. Curve, oxyhemoglobin, carboxyhemoglobin, carbon-monoxide JPI DEVICE, HEMATOCRIT MEASURING 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 CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry 2 CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph Clinical Chemistry 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 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 KHP Acid, Lactic, Enzymatic Method Clinical Chemistry 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00385480115339 Primary GS1 0 00385489115330 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 00385480115339 00385480115339 385480115339 0385480115339 00385489115330 00385489115330 385489115330 0385489115330
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 Storage Environment Temperature 15 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 070617139 Device count 100 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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