DEVICE: ABL80 SC80 (05700699457172)

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Device Identifier (DI) Information

ABL80 SC80
945-717
945-717
Radiometer Medical ApS
05700699457172
GS1
1
SC80 300/15 BG/OX, QC3
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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
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
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
JPI DEVICE, HEMATOCRIT MEASURING
CGA GLUCOSE OXIDASE, GLUCOSE
GHS ASSAY, CARBOXYHEMOGLOBIN
GKR SYSTEM, HEMOGLOBIN, AUTOMATED
JJY Multi-analyte controls, all kinds (assayed)
GLY OXIMETER TO MEASURE HEMOGLOBIN
JFP ELECTRODE, ION SPECIFIC, CALCIUM
DQA Oximeter
JGS ELECTRODE, ION SPECIFIC, SODIUM
JJI ANALYZER, ENZYME, FOR CLINICAL USE
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 5 and 25 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Status

Not in Commercial Distribution
September 01, 2016
January 10, 2017
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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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+459999999999
radiometer@radiometer.dk
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