DEVICE: D8088+D8089 Crea membrane A+B (05700699420732)

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Device Identifier (DI) Information

D8088+D8089 Crea membrane A+B
942-073
942-073
Radiometer Medical ApS
05700699420732
GS1
1
D8088+D8089 Crea membrane box A+B, with 2xA and 2xB membrane units, for ABL8XX
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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
Creatinine IVD, reagent A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of creatinine 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
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
CHL ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
KQI ASSAY, FETAL HEMOGLOBIN
CGA GLUCOSE OXIDASE, GLUCOSE
JFP ELECTRODE, ION SPECIFIC, CALCIUM
JGS ELECTRODE, ION SPECIFIC, SODIUM
GHS ASSAY, CARBOXYHEMOGLOBIN
CIG DIAZO COLORIMETRY, BILIRUBIN
KHP ACID, LACTIC, ENZYMATIC METHOD
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Sterilization

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

[?]
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

[?]
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)

[?]
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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