DEVICE: Calibration Solution (05700699440211)

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Device Identifier (DI) Information

Calibration Solution
944-021
944-021
Radiometer Medical ApS
05700699440211
GS1
4
S7770 tHb calibration Solution (box of 4 ampoules), for ABL7XX/8XX
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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 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
CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
JFP ELECTRODE, ION SPECIFIC, CALCIUM
GKF INSTRUMENT, HEMATOCRIT, AUTOMATED
CGA GLUCOSE OXIDASE, GLUCOSE
KHP ACID, LACTIC, ENZYMATIC METHOD
CIG DIAZO COLORIMETRY, BILIRUBIN
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
MQM BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
JGS ELECTRODE, ION SPECIFIC, SODIUM
JJS CONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED)
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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
Special Storage Condition, Specify: Keep away from sunlight
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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: 55700699440216 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+459999999999
radiometer@radiometer.dk
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