DEVICE: ABL90 FLEX SP90 (05700699444578)

Device Identifier (DI) Information

ABL90 FLEX SP90
944-457
In Commercial Distribution
944-457
Radiometer Medical ApS
05700699444578
GS1

1
308667539 *Terms of Use
Solution pack XL for ABL90 FLEX and ABL90 FLEX PLUS
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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).
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FDA Product Code

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Product Code Product Code Name
CHL ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
JFP ELECTRODE, ION SPECIFIC, CALCIUM
GKR SYSTEM, HEMOGLOBIN, AUTOMATED
MQM BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
JIX CALIBRATOR, MULTI-ANALYTE MIXTURE
JGS ELECTRODE, ION SPECIFIC, SODIUM
JJY Multi-analyte controls, all kinds (assayed)
GHS ASSAY, CARBOXYHEMOGLOBIN
CGA GLUCOSE OXIDASE, GLUCOSE
KHP ACID, LACTIC, ENZYMATIC METHOD
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
KQI ASSAY, FETAL HEMOGLOBIN
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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

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Storage and Handling
Special Storage Condition, Specify: Keep/Store away from clothing/…/combustible materials
Storage Environment Temperature: between 2 and 25 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

d9b86ec3-57d3-4616-baa3-b7dbb105eeb2
March 29, 2018
2
September 01, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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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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