DEVICE: REF 905-917 ABL90 FLEX sBOX (05700699059178)
Device Identifier (DI) Information
REF 905-917 ABL90 FLEX sBOX
905-917
Not in Commercial Distribution
905-917
Radiometer Medical ApS
905-917
Not in Commercial Distribution
905-917
Radiometer Medical ApS
Solution box for the ABL90 FLEX, SBOX
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? |
---|---|---|---|---|
56667 | Metabolic profile clinical chemistry analyser IVD |
A portable, electrically-powered automated or semi-automated laboratory instrument intended to be 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 in addition haemoximetry parameters [e.g., carboxy-haemoglobin (COHb), methaemoglobin (MetHb), total haemoglobin (totHb), hematrocrit (Hct)].
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JGS | ELECTRODE, ION SPECIFIC, SODIUM |
KHP | ACID, LACTIC, ENZYMATIC METHOD |
JIX | Calibrator, multi-analyte mixture |
CHL | Electrode measurement, blood-gases (pco2, po2) and blood ph |
GHS | ASSAY, CARBOXYHEMOGLOBIN |
KQI | ASSAY, FETAL HEMOGLOBIN |
CEM | ELECTRODE, ION SPECIFIC, POTASSIUM |
JJY | Multi-analyte controls, all kinds (assayed) |
CGZ | ELECTRODE, ION-SPECIFIC, CHLORIDE |
JFP | ELECTRODE, ION SPECIFIC, CALCIUM |
MQM | BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM |
CGA | GLUCOSE OXIDASE, GLUCOSE |
GKR | SYSTEM, HEMOGLOBIN, AUTOMATED |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
62749892-c52c-4050-9809-8e898df802ac
January 04, 2024
3
September 21, 2018
January 04, 2024
3
September 21, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
+45999999999
radiometer@radiometer.dk
radiometer@radiometer.dk