DEVICE: ABL800 FLEX (05700693938004)

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Device Identifier (DI) Information

ABL800 FLEX
393-800

Radiometer Medical ApS
05700693938004
GS1
1
ABL800 FLEX
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Device Characteristics

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

GMDN

[?]

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, stationary, automated A stationary mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro measurement of multiple clinical chemisty analytes to generate a metabolic profile. Analytes may include pH, blood gas parameters [e.g., partial pressure of oxygen (pO2), partial pressure of carbon dioxide (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)]. The device operates with minimal technician involvement and complete 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
MQM BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
CGA GLUCOSE OXIDASE, GLUCOSE
KQI ASSAY, FETAL HEMOGLOBIN
JGS ELECTRODE, ION SPECIFIC, SODIUM
CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
JFP ELECTRODE, ION SPECIFIC, CALCIUM
CIG DIAZO COLORIMETRY, BILIRUBIN
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
CGL ELECTRODE, ION BASED, ENZYMATIC, CREATININE
GHS ASSAY, CARBOXYHEMOGLOBIN
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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
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 60 and 107 KiloPascal
Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
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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

[?]
+459999999999
radiometer@radiometer.dk
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