DEVICE: ABL90 FLEX Analyzer (05700693930909)
Device Identifier (DI) Information
ABL90 FLEX Analyzer
393-090
In Commercial Distribution
393-090
Radiometer Medical ApS
393-090
In Commercial Distribution
393-090
Radiometer Medical ApS
ABL90 FLEX, Analyzer without casettes, cables, manuals etc.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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56667 | Metabolic profile clinical chemistry analyser IVD |
A 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)].
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH |
KHP | ACID, LACTIC, ENZYMATIC METHOD |
JGS | ELECTRODE, ION SPECIFIC, SODIUM |
CGZ | ELECTRODE, ION-SPECIFIC, CHLORIDE |
JFP | ELECTRODE, ION SPECIFIC, CALCIUM |
JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE |
CEM | ELECTRODE, ION SPECIFIC, POTASSIUM |
KQI | ASSAY, FETAL HEMOGLOBIN |
JJY | Multi-analyte controls, all kinds (assayed) |
CGA | GLUCOSE OXIDASE, GLUCOSE |
GHS | ASSAY, CARBOXYHEMOGLOBIN |
GKR | SYSTEM, HEMOGLOBIN, AUTOMATED |
MQM | BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Environmental specification 30-32 °C: Barometric pressure 80.0-106.7 kPa. Environmental specification 15-30 °C: Barometric pressure 70.0-106.7 kPa |
Handling Environment Atmospheric Pressure: between 70 and 107 KiloPascal |
Handling Environment Humidity: between 10 and 80 Percent (%) Relative Humidity |
Storage Environment Temperature: between -20 and 60 Degrees Celsius |
Handling Environment Temperature: between 15 and 32 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
65a62230-1741-4952-85d1-c8823af178b0
November 14, 2024
5
September 01, 2016
November 14, 2024
5
September 01, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+459999999999
radiometer@radiometer.dk
radiometer@radiometer.dk