Home GUDID 05700693930923 ABL90 FLEX PLUS Analyzer
Primary DI 05700693930923
Brand ABL90 FLEX PLUS Analyzer
Company Radiometer Medical ApS
Model 393-092
Catalog number 393-092
Device description ABL90 FLEX PLUS, Analyzer without casettes, cables, manuals etc.
Published 2017-02-15
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 GHS ASSAY, CARBOXYHEMOGLOBIN GKR SYSTEM, HEMOGLOBIN, AUTOMATED JFP ELECTRODE, ION SPECIFIC, CALCIUM JGS ELECTRODE, ION SPECIFIC, SODIUM JIX CALIBRATOR, MULTI-ANALYTE MIXTURE JJY Multi-analyte controls, all kinds (assayed) KHP ACID, LACTIC, ENZYMATIC METHOD KQI ASSAY, FETAL HEMOGLOBIN MQM BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
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 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 JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry 1 KHP Acid, Lactic, Enzymatic Method Clinical Chemistry 1 KQI Assay, Fetal Hemoglobin Hematology 2 MQM Bilirubin (Total And Unbound) In The Neonate Test System Clinical Chemistry 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05700693930923 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05700693930923 05700693930923 5700693930923
GMDN Terms# Term, Definition table Term Definition Metabolic profile clinical chemistry analyser IVD, portable, automated A portable mains electricity (AC-powered) laboratory instrument, typically with rechargeable batteries for power at the point-of-care in acute care settings, intended 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 haemoximetry parameters [e.g., carboxy-haemoglobin (COHb), methaemoglobin (MetHb), total haemoglobin (totHb), hematrocrit (Hct)]. It operates with minimal technician involvement and automation of all procedural steps.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 70 KiloPascal 107 KiloPascal Handling Environment Humidity 10 Percent (%) Relative Humidity 80 Percent (%) Relative Humidity Handling Environment Humidity 20 Percent (%) Relative Humidity 80 Percent (%) Relative Humidity Handling Environment Temperature 15 Degrees Celsius 32 Degrees Celsius Special Storage Condition, Specify 0 0 Labeling does not contain MRI Safety information Storage Environment Temperature -20 Degrees Celsius 60 Degrees Celsius
Regulatory Flags# DUNS number 308667539 Device count 1 Lot or batch true Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 05700693930978 ABL90 FLEX 393-097 393-097 2026-07-09 05700693930985 ABL90 FLEX PLUS 393-098 393-098 2026-07-09 05700699446572 SP90 944-657 944-657 2026-07-09 05700699447579 SP90 944-757 944-757 2026-07-09 05700699461056 SC90 946-105 946-105 2026-07-09 05700699461087 SC90 946-108 946-108 2026-07-09 05700699461094 SC90 946-109 946-109 2026-07-09 05700699461100 SC90 946-110 946-110 2026-07-09 05700699461131 SC90 946-113 946-113 2026-07-09 05700699461605 SC90 946-160 946-160 2026-07-09 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
Other Devices Sharing Product Codes# 
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