DEVICE: I.S.E. REF (05055273214895)

Device Identifier (DI) Information

I.S.E. REF
D400-0010
In Commercial Distribution
D400-0010
RANDOX LABORATORIES LIMITED
05055273214895
GS1

1
227530649 *Terms of Use
Intended for use with the Ion Selective Electrode unit for measuring concentration of electrolytes in the blood serum, plasma or urine.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
No
No

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Reference electrode IVD An electrochemical sensor intended to be used as a known reference for electrical potential in an assay that is used for the quantitative measurement of one or multiple electrolytes in a clinical specimen.
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FDA Product Code

[?]
Product Code Product Code Name
CGZ Electrode, Ion-Specific, Chloride
CEM Electrode, Ion Specific, Potassium
JGS Electrode, Ion Specific, Sodium
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K131554 000
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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 15 and 25 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

9ed6030c-2ea6-49dc-9163-2c270d3288a9
July 06, 2018
3
September 26, 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

[?]
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

[?]
+44289445170
technical.services@randox.com
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