DEVICE: ABL80 CO-OX Capillary adapter (05700699060259)

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Device Identifier (DI) Information

ABL80 CO-OX Capillary adapter
906-025
906-025
Radiometer Medical ApS
05700699060259
GS1
100
ABL80 CO-OX Capillary adapter
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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
JGS ELECTRODE, ION SPECIFIC, SODIUM
JJI ANALYZER, ENZYME, FOR CLINICAL USE
JPI DEVICE, HEMATOCRIT MEASURING
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
GHS ASSAY, CARBOXYHEMOGLOBIN
JFP ELECTRODE, ION SPECIFIC, CALCIUM
JJY Multi-analyte controls, all kinds (assayed)
GLY OXIMETER TO MEASURE HEMOGLOBIN
DQA Oximeter
CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
GKR SYSTEM, HEMOGLOBIN, AUTOMATED
CGA GLUCOSE OXIDASE, GLUCOSE
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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
No storage/handling found
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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: 55700699060254 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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