Home GUDID 05700699457103 ABL80 SC80
Primary DI 05700699457103
Brand ABL80 SC80
Company Radiometer Medical ApS
Model 945-710
Catalog number 945-710
Device description SC80 300/30 Full-OX noGlu, QC3
Published 2016-09-01
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 CGA GLUCOSE OXIDASE, GLUCOSE CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE CHL ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH DQA Oximeter GHS ASSAY, CARBOXYHEMOGLOBIN GKR SYSTEM, HEMOGLOBIN, AUTOMATED GLY OXIMETER TO MEASURE HEMOGLOBIN JFP ELECTRODE, ION SPECIFIC, CALCIUM JGS ELECTRODE, ION SPECIFIC, SODIUM JJI ANALYZER, ENZYME, FOR CLINICAL USE JJY Multi-analyte controls, all kinds (assayed) JPI DEVICE, HEMATOCRIT MEASURING
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class CEM Electrode, Ion Specific, Potassium Clinical Chemistry 2 CGA Glucose Oxidase, Glucose Clinical Chemistry 2 CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry 2 CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph Clinical Chemistry 2 DQA Oximeter Cardiovascular 2 GHS Assay, Carboxyhemoglobin Hematology 2 GKR System, Hemoglobin, Automated 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 JJI Analyzer, Enzyme, For Clinical Use Clinical Chemistry 1 JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry 1 JPI Device, Hematocrit Measuring Hematology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05700699457103 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05700699457103 05700699457103 5700699457103
GMDN Terms# Term, Definition table Term Definition Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies A collection of reagents and other associated materials intended to be used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample, using multiple technologies such as ion-selective electrode (ISE) and haemoximetry in a single analyser. Analytes detected may include partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, sodium, potassium, ionized calcium, chloride, glucose, lactate, total haemoglobin (totHb), haematocrit, and haemoglobin derivatives such as reduced haemoglobin (RHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb).
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 5 Degrees Celsius 25 Degrees Celsius
Regulatory Flags# DUNS number 308667539 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 05700699428929 SAFE CLINIT. D957P-70-100X1 942-892 942-892 2022-12-05 05700699428936 SAFE CLINIT. D957P-70-125X1 942-893 942-893 2022-12-05 05700699428981 SAFE CLINITUBES D957P-70-70X1 942-898 942-898 2024-07-01 05700699429698 safeClinitubes D957P-70-45 942-969 942-969 2022-12-05 05700699440174 QUALICHECK 5+, LEVEL 1 944-017 944-017 2022-12-05 05700699440198 QUALICHECK 5+, LEVEL 3 944-019 944-019 2022-12-05 05700699440822 AUTOCHECK 3+, LEVEL 1, S7335 944-082 944-082 2022-12-05 05700699440839 AUTOCHECK 3+, LEVEL 2, S7345 944-083 944-083 2022-12-05 05700699440846 AUTOCHECK 3+, LEVEL 3, S7355 944-084 944-084 2022-12-05 05700699440853 AUTOCHECK 3+, LEVEL 4, S7365 944-085 944-085 2022-12-05 05700699058027 Disposable Waste Container D513 REF 905-802 905-802 905-802 2018-09-21 05700699058713 Membraning kit for tc sensor 84 905-871 905-871 2016-09-01 05700699060266 ABL90 FLEX, Clot catcher 906-026 906-026 2016-09-01 05700699420589 Membrane for E1001 electrode 942-058 942-058 2016-09-01 05700699420633 Membrane for E788 electrode 942-063 942-063 2016-09-01 05700699420640 Membrane for E799 electrode 942-064 942-064 2016-09-01 05700699420664 Membrane for E7077 electrode 942-066 942-066 2016-09-01 05700699439062 S5362 REF 943-906 943-906 943-906 2018-09-21 05700699440211 Calibration Solution 944-021 944-021 2016-09-01 05700699441263 Cleaning Solution with additive S8375 REF 944-126 944-126 944-126 2018-09-21
Other Devices Sharing Product Codes# 
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