DEVICE: Crea Calibration Solution 2 (05700699441348)

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Device Identifier (DI) Information

Crea Calibration Solution 2
944-134
944-134
Radiometer Medical ApS
05700699441348
GS1
1
S1837 Crea Calibration Solution 2, membrane bottle, 6x140 mL, for ABL8XX
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
CGL ELECTRODE, ION BASED, ENZYMATIC, CREATININE
CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
MQM BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
GHS ASSAY, CARBOXYHEMOGLOBIN
KHP ACID, LACTIC, ENZYMATIC METHOD
KQI ASSAY, FETAL HEMOGLOBIN
JFP ELECTRODE, ION SPECIFIC, CALCIUM
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
CHL ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
CIG DIAZO COLORIMETRY, BILIRUBIN
JGS ELECTRODE, ION SPECIFIC, SODIUM
CGA GLUCOSE OXIDASE, GLUCOSE
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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 10 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
15700699441345 6 05700699441348 In Commercial Distribution
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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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