DEVICE: ABX PENTRA POTASSIUM-E (03610230005859)

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Device Record History
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Device Identifier (DI) Information
ABX PENTRA POTASSIUM-E
3014029450
In Commercial Distribution

HORIBA ABX SAS
03610230005859
GS1

1
273647420 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
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No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
59248 Potassium (K+) electrode IVD
An electrochemical sensor intended to be used to selectively measure electrical potential against a reference electrode to determine the concentration of potassium (K+) ions in a clinical specimen.
Active false
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FDA Product Code

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Product Code Product Code Name
CEM Electrode, Ion Specific, Potassium
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K052007 000
No CLOSE

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
0c91ff53-45f0-4dd8-924e-c68486b7d585
July 06, 2018
3
August 23, 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: 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
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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