Home GUDID 05700693938011 ABL800 FLEX
Primary DI 05700693938011
Brand ABL800 FLEX
Company Radiometer Medical ApS
Model 393-801
Catalog number 393-801
Device description ABL800 FLEX with crea
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 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 JFP ELECTRODE, ION SPECIFIC, CALCIUM JGS ELECTRODE, ION SPECIFIC, SODIUM 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 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 JFP Electrode, Ion Specific, Calcium Clinical Chemistry 2 JGS Electrode, Ion Specific, Sodium Clinical Chemistry 2 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 05700693938011 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05700693938011 05700693938011 5700693938011
GMDN Terms# Term, Definition table Term Definition Metabolic profile clinical chemistry analyser IVD, stationary, automated A stationary mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro measurement of multiple clinical chemisty analytes to generate a metabolic profile. Analytes may include pH, blood gas parameters [e.g., partial pressure of oxygen (pO2), partial pressure of carbon dioxide (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)]. The device operates with minimal technician involvement and complete automation of all procedural steps.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 60 KiloPascal 107 KiloPascal 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 Environmental specification 30-32 °C: Barometric pressure 80.0-106.7 kPa. Environmental specification 15-30 °C: Barometric pressure 70.0-106.7 kPa Storage Environment Temperature -20 Degrees Celsius 60 Degrees Celsius
Regulatory Flags# DUNS number 308667539 Device count 1 Lot or batch 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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