DEVICE: REF 905-956 ABL90 FLEX sBOX PLUS (05700699059567)

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Device Record History
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Device Identifier (DI) Information
REF 905-956 ABL90 FLEX sBOX PLUS
905-956
Not in Commercial Distribution
905-956
Radiometer Medical ApS
05700699059567
GS1
November 30, 2023
1
308667539 *Terms of Use
Solution box for ABL90FLEX PLUS SBOX PLUS
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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?
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)].
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GHS ASSAY, CARBOXYHEMOGLOBIN
MQM BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
JIX Calibrator, multi-analyte mixture
JFP ELECTRODE, ION SPECIFIC, CALCIUM
GKR SYSTEM, HEMOGLOBIN, AUTOMATED
KQI ASSAY, FETAL HEMOGLOBIN
JGS ELECTRODE, ION SPECIFIC, SODIUM
KHP ACID, LACTIC, ENZYMATIC METHOD
CHL Electrode measurement, blood-gases (pco2, po2) and blood ph
JJY Multi-analyte controls, all kinds (assayed)
CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
CGA GLUCOSE OXIDASE, GLUCOSE
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
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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
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
ccf61968-7175-4e47-b642-849e9df4fb23
January 05, 2024
3
September 21, 2018
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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

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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

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
+45999999999
radiometer@radiometer.dk
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