DEVICE: Test Cartridge (06944413802872)

Device Identifier (DI) Information

Test Cartridge
BG8
In Commercial Distribution

Edan Instruments, Inc.
06944413802872
GS1

1
529173163 *Terms of Use
No description.
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Multiple blood gas analyte IVD, kit, ion-selective electrode (ISE) A collection of reagents and other associated materials intended to be used for the quantitative measurement of one or multiple blood gas analytes in a clinical specimen, 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
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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

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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

f7b99feb-2f01-4f1d-ae7f-9bbe4be5ed74
March 29, 2018
2
September 01, 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
06944413802865 4 06944413801912 In Commercial Distribution
06944413801912 25 06944413802872 In Commercial Distribution
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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
Yes
Yes
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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