DEVICE: ABL90 FLEX Analyzer (05700693930909)

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Device Identifier (DI) Information

ABL90 FLEX Analyzer
393-090
393-090
Radiometer Medical ApS
05700693930909
GS1
1
ABL90 FLEX, Analyzer without casettes, cables, manuals etc.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Metabolic profile clinical chemistry analyser IVD, portable, automated A 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.
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FDA Product Code

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Product Code Product Code Name
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
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Handling Environment Temperature: between 15 and 32 Degrees Celsius
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Handling Environment Atmospheric Pressure: between 70 and 107 KiloPascal
Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
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
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 01, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

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+459999999999
radiometer@radiometer.dk
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