DEVICE: AU (15099590060206)

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Device Record History
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Device Identifier (DI) Information
AU
OSR6637
In Commercial Distribution

Beckman Coulter, Inc.
15099590060206
GS1

1
008254708 *Terms of Use
Bicarbonate
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
No
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?
59054 Bicarbonate (HCO3-) IVD, kit, enzyme spectrophotometry
A collection of reagents and other associated materials intended to be used for the quantitative measurement of bicarbonate (HCO3-) in a clinical specimen, using an enzyme spectrophotometry method.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
KHS Enzymatic, Carbon-Dioxide
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K131546 000
No CLOSE

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
797a4dd4-996d-4284-a3f0-40d811247305
July 06, 2018
3
September 24, 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: 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
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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