DEVICE: SC90 50 BG, LYT, MET, OXI + QC (05700699460509)

Device Identifier (DI) Information

SC90 50 BG, LYT, MET, OXI + QC
946-050
In Commercial Distribution
946-050
Radiometer Medical ApS
05700699460509
GS1

1
308667539 *Terms of Use
SC90 50 BG, LYT, MET, OXI + QC
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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. 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
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
KHP ACID, LACTIC, ENZYMATIC METHOD
CGA GLUCOSE OXIDASE, GLUCOSE
JJY Multi-analyte controls, all kinds (assayed)
CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
JGS ELECTRODE, ION SPECIFIC, SODIUM
GHS ASSAY, CARBOXYHEMOGLOBIN
MQM BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
KQI ASSAY, FETAL HEMOGLOBIN
CHL Electrode measurement, blood-gases (pco2, po2) and blood ph
JIX Calibrator, multi-analyte mixture
JFP Electrode, ion specific, calcium
GKR SYSTEM, HEMOGLOBIN, AUTOMATED
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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 2 and 8 Degrees Celsius
Special Storage Condition, Specify: Keep away from sunlight
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

b7232612-1479-40ab-a7d5-62b4fda012de
July 09, 2024
1
July 01, 2024
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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
Yes
No CLOSE

Customer Contact

[?]
+45999999999
radiometer@radiometer.dk
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