DEVICE: Membrane for E755 electrode (05700699420626)

Device Identifier (DI) Information

Membrane for E755 electrode
942-062
In Commercial Distribution
942-062
Radiometer Medical ApS
05700699420626
GS1

4
308667539 *Terms of Use
D755 Na membrane box (4 units) 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

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Sodium (Na+) IVD, kit, ion-selective electrode (ISE) A collection of reagents and other associated materials intended to be used for the quantitative measurement of sodium (Na+) in a clinical specimen, using an ion-selective electrode (ISE) method.
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FDA Product Code

[?]
Product Code Product Code Name
JGS ELECTRODE, ION SPECIFIC, SODIUM
CHL ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
CGL ELECTRODE, ION BASED, ENZYMATIC, CREATININE
KQI ASSAY, FETAL HEMOGLOBIN
CGA GLUCOSE OXIDASE, GLUCOSE
CIG DIAZO COLORIMETRY, BILIRUBIN
CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
GHS ASSAY, CARBOXYHEMOGLOBIN
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
KHP ACID, LACTIC, ENZYMATIC METHOD
JFP ELECTRODE, ION SPECIFIC, CALCIUM
MQM BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

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 32 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

78ce8cf2-9320-40b9-a375-88603072d7af
March 29, 2018
2
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

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 55700699420621 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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