DEVICE: Calibration Solution (05700699440242)

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Device Identifier (DI) Information

Calibration Solution
944-024
944-024
Radiometer Medical ApS
05700699440242
GS1
1
S1720 Calibration Solution 1 200 mL, for ABL7XX
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Multiple blood gas analyte IVD, calibrator A material which is used to establish known points of reference for a number of assays intended to be used for the quantitative measurement of one or multiple blood gas analytes in a clinical specimen.
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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
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
JFP ELECTRODE, ION SPECIFIC, CALCIUM
CIG DIAZO COLORIMETRY, BILIRUBIN
GKF INSTRUMENT, HEMATOCRIT, AUTOMATED
MQM BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
KHP ACID, LACTIC, ENZYMATIC METHOD
JJS CONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED)
CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
CGA GLUCOSE OXIDASE, GLUCOSE
JGS ELECTRODE, ION SPECIFIC, SODIUM
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
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 Status

In Commercial Distribution
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)

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No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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+459999999999
radiometer@radiometer.dk
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