FDA.reportPublic FDA data

ABL80 CO-OX Capillary adapter

Primary DI
05700699060259
Brand
ABL80 CO-OX Capillary adapter
Company
Radiometer Medical ApS
Model
906-025
Catalog number
906-025
Device description
ABL80 CO-OX Capillary adapter
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
05700699060259PrimaryGS10
55700699060254Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700699060259057006990602595700699060259
5570069906025455700699060254

GMDN Terms#

Term, Definition table
TermDefinition
Metabolic profile clinical chemistry analyser IVDA portable, electrically-powered automated or semi-automated laboratory instrument 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)].

Contacts#

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

Regulatory Flags#

DUNS number
308667539
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05700699058683Membraning kit for tc sensor 54905-868905-8682016-09-01
05700699428905SAFE CLINIT. D941P-240-85X1942-890942-8902022-12-05
05700699428929SAFE CLINIT. D957P-70-100X1942-892942-8922022-12-05
05700699428936SAFE CLINIT. D957P-70-125X1942-893942-8932022-12-05
05700699429698safeClinitubes D957P-70-45942-969942-9692022-12-05
05700699058669Electrolyte 54905-866905-8662016-09-01
05700699456052Electrode for ABL analyzers945-605945-6052016-09-01
05700699565259PICO70956-525956-5252016-09-01
05700699565334PICO70956-533956-5332016-09-01
05700699565471PICO70956-547956-5472016-09-01
05700699566089safePICO70956-608956-6082016-09-01
05700699566096safePICO70956-609956-6092016-09-01
05700699566126safePICO70956-612956-6122016-09-01
05700699566133safePICO70956-613956-6132016-09-01
05700699566140safePICO70956-614956-6142016-09-01
05700699566157safePICO70956-615956-6152016-09-01
05700699566164safePICO70956-616956-6162016-09-01
05700699566232safePICO956-623956-6232016-09-01
05700699566249safePICO70956-624956-6242016-09-01
05700699056894TC contact liquid905-689905-6892016-09-01

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