DEVICE: ABL80 FLEX SP80 (05700699441744)

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Device Identifier (DI) Information

ABL80 FLEX SP80
944-174
944-174
Radiometer Medical ApS
05700699441744
GS1
1
ABL80 FLEX Solution pack
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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
Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies A collection of reagents and other associated materials intended to be used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample, using multiple technologies such as ion-selective electrode (ISE) and haemoximetry in a single analyser. Analytes detected may include partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, sodium, potassium, ionized calcium, chloride, glucose, lactate, total haemoglobin (totHb), haematocrit, and haemoglobin derivatives such as reduced haemoglobin (RHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb).
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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
DQA Oximeter
GKR SYSTEM, HEMOGLOBIN, AUTOMATED
CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
CGA GLUCOSE OXIDASE, GLUCOSE
JJY Multi-analyte controls, all kinds (assayed)
GHS ASSAY, CARBOXYHEMOGLOBIN
JPI DEVICE, HEMATOCRIT MEASURING
JGS ELECTRODE, ION SPECIFIC, SODIUM
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
JIX CALIBRATOR, MULTI-ANALYTE MIXTURE
JFP ELECTRODE, ION SPECIFIC, CALCIUM
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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
Storage Environment Temperature: between 5 and 25 Degrees Celsius
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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
Yes
No
No CLOSE

Customer Contact

[?]
+459999999999
radiometer@radiometer.dk
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