DEVICE: ABL80 SC80 (05700699457141)

Device Identifier (DI) Information

ABL80 SC80
945-714
In Commercial Distribution
945-714
Radiometer Medical ApS
05700699457141
GS1

1
308667539 *Terms of Use
SC80 100/30 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© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
52858 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).
Active false
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FDA Product Code

[?]
Product Code Product Code Name
CHL ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
GKR SYSTEM, HEMOGLOBIN, AUTOMATED
CGA GLUCOSE OXIDASE, GLUCOSE
DQA Oximeter
CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
JFP ELECTRODE, ION SPECIFIC, CALCIUM
GHS ASSAY, CARBOXYHEMOGLOBIN
JJI ANALYZER, ENZYME, FOR CLINICAL USE
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
GLY OXIMETER TO MEASURE HEMOGLOBIN
JJY Multi-analyte controls, all kinds (assayed)
JGS ELECTRODE, ION SPECIFIC, SODIUM
JPI DEVICE, HEMATOCRIT MEASURING
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

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 Record Status

09db2f86-ebf5-4bd6-8a92-2a0c8ecc5923
November 27, 2020
3
September 01, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

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

[?]
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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