DEVICE: Crea Calibration Solution 1 (05700699441355)

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Device Identifier (DI) Information

Crea Calibration Solution 1
944-135
944-135
Radiometer Medical ApS
05700699441355
GS1
1
S1827 Crea Calibration Solution 1, membrane bottle, 6x175 mL, for ABL8XX, USA
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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
CIG DIAZO COLORIMETRY, BILIRUBIN
JFP ELECTRODE, ION SPECIFIC, CALCIUM
CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
MQM BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
CHL ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
JGS ELECTRODE, ION SPECIFIC, SODIUM
KHP ACID, LACTIC, ENZYMATIC METHOD
CGA GLUCOSE OXIDASE, GLUCOSE
GHS ASSAY, CARBOXYHEMOGLOBIN
KQI ASSAY, FETAL HEMOGLOBIN
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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
15700699441352 6 05700699441355 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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