DEVICE: ABL80 SC80 (05700699457004)
Device Identifier (DI) Information
ABL80 SC80
945-700
In Commercial Distribution
945-700
Radiometer Medical ApS
945-700
In Commercial Distribution
945-700
Radiometer Medical ApS
SC80 25/30 Full-OX, QC3
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. 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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH |
CGA | GLUCOSE OXIDASE, GLUCOSE |
GHS | ASSAY, CARBOXYHEMOGLOBIN |
GLY | OXIMETER TO MEASURE HEMOGLOBIN |
JJI | ANALYZER, ENZYME, FOR CLINICAL USE |
JJY | Multi-analyte controls, all kinds (assayed) |
JPI | DEVICE, HEMATOCRIT MEASURING |
GKR | SYSTEM, HEMOGLOBIN, AUTOMATED |
JFP | ELECTRODE, ION SPECIFIC, CALCIUM |
CGZ | ELECTRODE, ION-SPECIFIC, CHLORIDE |
DQA | Oximeter |
CEM | ELECTRODE, ION SPECIFIC, POTASSIUM |
JGS | ELECTRODE, ION SPECIFIC, SODIUM |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 5 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
7d512366-e562-4944-af03-0052f902185f
November 27, 2020
3
September 01, 2016
November 27, 2020
3
September 01, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+459999999999
radiometer@radiometer.dk
radiometer@radiometer.dk