FDA.reportPublic FDA data

ABL80 FLEX CO-OX Analyzer

Primary DI
05700693938417
Brand
ABL80 FLEX CO-OX Analyzer
Company
Radiometer Medical ApS
Model
393-841
Catalog number
393-841
Device description
ABL80 FLEX CO-OX, Analyzer
Published
2016-09-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CEMELECTRODE, ION SPECIFIC, POTASSIUM
CGAGLUCOSE OXIDASE, GLUCOSE
CGZELECTRODE, ION-SPECIFIC, CHLORIDE
CHLELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
DQAOximeter
GHSASSAY, CARBOXYHEMOGLOBIN
GKRSYSTEM, HEMOGLOBIN, AUTOMATED
GLYOXIMETER TO MEASURE HEMOGLOBIN
JFPELECTRODE, ION SPECIFIC, CALCIUM
JGSELECTRODE, ION SPECIFIC, SODIUM
JJIANALYZER, ENZYME, FOR CLINICAL USE
JJYMulti-analyte controls, all kinds (assayed)
JPIDEVICE, HEMATOCRIT MEASURING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEMElectrode, Ion Specific, PotassiumClinical Chemistry2
CGAGlucose Oxidase, GlucoseClinical Chemistry2
CGZElectrode, Ion-Specific, ChlorideClinical Chemistry2
CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhClinical Chemistry2
DQAOximeterCardiovascular2
GHSAssay, CarboxyhemoglobinHematology2
GKRSystem, Hemoglobin, AutomatedHematology2
GLYOximeter To Measure HemoglobinHematology2
JFPElectrode, Ion Specific, CalciumClinical Chemistry2
JGSElectrode, Ion Specific, SodiumClinical Chemistry2
JJIAnalyzer, Enzyme, For Clinical UseClinical Chemistry1
JJYMulti-Analyte Controls, All Kinds (Assayed)Clinical Chemistry1
JPIDevice, Hematocrit MeasuringHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700693938417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700693938417057006939384175700693938417

GMDN Terms#

Term, Definition table
TermDefinition
Metabolic profile clinical chemistry analyser IVD, portable, automatedA 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
TypeLowHighCondition
Special Storage Condition, Specify00Fragile

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+459999999999radiometer@radiometer.dk

Regulatory Flags#

DUNS number
308667539
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05700699428929SAFE CLINIT. D957P-70-100X1942-892942-8922022-12-05
05700699428936SAFE CLINIT. D957P-70-125X1942-893942-8932022-12-05
05700699428981SAFE CLINITUBES D957P-70-70X1942-898942-8982024-07-01
05700699429698safeClinitubes D957P-70-45942-969942-9692022-12-05
05700699440174QUALICHECK 5+, LEVEL 1944-017944-0172022-12-05
05700699440198QUALICHECK 5+, LEVEL 3944-019944-0192022-12-05
05700699440822AUTOCHECK 3+, LEVEL 1, S7335944-082944-0822022-12-05
05700699440839AUTOCHECK 3+, LEVEL 2, S7345944-083944-0832022-12-05
05700699440846AUTOCHECK 3+, LEVEL 3, S7355944-084944-0842022-12-05
05700699440853AUTOCHECK 3+, LEVEL 4, S7365944-085944-0852022-12-05
05700699058027Disposable Waste Container D513 REF 905-802905-802905-8022018-09-21
05700699058713Membraning kit for tc sensor 84905-871905-8712016-09-01
05700699060266ABL90 FLEX, Clot catcher906-026906-0262016-09-01
05700699420589Membrane for E1001 electrode942-058942-0582016-09-01
05700699420633Membrane for E788 electrode942-063942-0632016-09-01
05700699420640Membrane for E799 electrode942-064942-0642016-09-01
05700699420664Membrane for E7077 electrode942-066942-0662016-09-01
05700699439062S5362 REF 943-906943-906943-9062018-09-21
05700699440211Calibration Solution944-021944-0212016-09-01
05700699441263Cleaning Solution with additive S8375 REF 944-126944-126944-1262018-09-21

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