DEVICE: Siemens (00850015517211)

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Device Record History
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Device Identifier (DI) Information
Siemens
11561694
In Commercial Distribution
11561694
KOVA INTERNATIONAL, INC.
00850015517211
GS1

1
078780990 *Terms of Use
UA Diptube Liquid QC
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
No
No
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?
42065 Urine sediment IVD, control
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or semi-quantitative screening of urine sediment.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
JJW Urinalysis Controls (Assayed And Unassayed)
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K843565 000
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 8 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
b07c5f2f-d329-42fa-9c4e-9b64a582cd74
March 11, 2022
1
March 03, 2022
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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
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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