DEVICE: Electrode for ABL analyzers (05700699453754)

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Device Identifier (DI) Information

Electrode for ABL analyzers
945-375
945-375
Radiometer Medical ApS
05700699453754
GS1
1
E808 pCO2 electrode Color-coded Green. for ABL5/50/5XX
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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
Blood gas pCO2 IVD, kit, ion-selective electrode (ISE) A collection of reagents and other associated materials intended to be used for the quantitative measurement of blood gas partial pressure of carbon dioxide (pCO2) using an ion-selective electrode (ISE) method.
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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
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 32 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
May 23, 2017

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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

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Yes
No
No
No
No CLOSE

Customer Contact

[?]
+459999999999
radiometer@radiometer.dk
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