FDA.reportPublic FDA data

ABL90 FLEX

Primary DI
05700693930978
Brand
ABL90 FLEX
Company
Radiometer Medical ApS
Model
393-097
Catalog number
393-097
Device description
ABL90 FLEX, Analyzer without cassettes, cables, manuals etc.
Published
2026-07-09
Public version status
New
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
GHSASSAY, CARBOXYHEMOGLOBIN
GKRSYSTEM, HEMOGLOBIN, AUTOMATED
JFPElectrode, ion specific, calcium
JGSELECTRODE, ION SPECIFIC, SODIUM
KHPACID, LACTIC, ENZYMATIC METHOD

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
GHSAssay, CarboxyhemoglobinHematology2
GKRSystem, Hemoglobin, AutomatedHematology2
JFPElectrode, Ion Specific, CalciumClinical Chemistry2
JGSElectrode, Ion Specific, SodiumClinical Chemistry2
KHPAcid, Lactic, Enzymatic MethodClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700693930978PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700693930978057006939309785700693930978

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)].

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Special Storage Condition, Specify00Labeling does not contain MRI Safety information
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+45999999999radiometer@radiometer.dk

Regulatory Flags#

DUNS number
308667539
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
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
05700693930985ABL90 FLEX PLUS393-098393-0982026-07-09
05700699446572SP90944-657944-6572026-07-09
05700699447579SP90944-757944-7572026-07-09
05700699461056SC90946-105946-1052026-07-09
05700699461087SC90946-108946-1082026-07-09
05700699461094SC90946-109946-1092026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14048534002469Hemo Control Hemoglobin MicrocuvetteEKF-diagnostic GmbHGKR2026-09-25
00384841518802Prodigy AutoCode Blood Glucose Monitoring SystemProdigy Diabetes Care, LLCCGA2026-08-13
04719893239003XPER Technology Lactate Monitoring System L1TAIDOC TECHNOLOGY CORPORATIONKHP2026-08-03
04719893239010XPER Technology Lactate Test Strips L1 (25pcs/box)TAIDOC TECHNOLOGY CORPORATIONKHP2026-08-03
14048534002742CleanerEKF-diagnostic GmbHGKR2026-07-31
24048534002749CleanerEKF-diagnostic GmbHGKR2026-07-31
34048534002456Hemo Control Hemoglobin MicrocuvetteEKF-diagnostic GmbHGKR2026-07-31
44048534002453Hemo Control Hemoglobin MicrocuvetteEKF-diagnostic GmbHGKR2026-07-31
04719869706904Tyson Bio AC500 PRO Blood Glucose Monitoring System (Meter Only) (FDA)TYSON BIORESEARCH INC.CGA2026-07-13
04719869706911TysonBio AC500 PRO Blood Glucose Test Strips (50T)TYSON BIORESEARCH INC.CGA2026-07-13
04719869706942Tyson Bio AC500 PRO Control Solution (Level 1) (FDA)TYSON BIORESEARCH INC.CGA2026-07-13
04719869706959Tyson Bio AC500 PRO Control Solution (Level 3) (FDA)TYSON BIORESEARCH INC.CGA2026-07-13
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSJGS2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSGHS2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSCEM2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSJFP2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSCGA2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSCHL2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSGKR2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSKHP2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSCGZ2026-07-09
05700699446572SP90Radiometer Medical ApSGKR2026-07-09
05700699446572SP90Radiometer Medical ApSKHP2026-07-09
05700699446572SP90Radiometer Medical ApSJFP2026-07-09
05700699446572SP90Radiometer Medical ApSJGS2026-07-09
05700699446572SP90Radiometer Medical ApSCGZ2026-07-09
05700699446572SP90Radiometer Medical ApSCGA2026-07-09
05700699446572SP90Radiometer Medical ApSGHS2026-07-09
05700699446572SP90Radiometer Medical ApSCEM2026-07-09
05700699446572SP90Radiometer Medical ApSCHL2026-07-09