DEVICE: Henry Schein (00304040004098)

Device Identifier (DI) Information

Henry Schein
1126841
In Commercial Distribution
1126841
HENRY SCHEIN, INC.
00304040004098
GS1

1
012430880 *Terms of Use
Urispec Urine Dropper Control
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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 urine analyte IVD, control A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or semi-quantitative screening of urine for multiple analytes.
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FDA Product Code

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Product Code Product Code Name
JJW URINALYSIS CONTROLS (ASSAYED AND UNASSAYED)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K890577 000
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Sterilization

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

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Storage and Handling
Special Storage Condition, Specify: Can be left at room temperature if used within 30 days
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Box = 3 X 2 X 15 ml
Total Volume: 15 Milliliter
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Device Record Status

150fa1aa-1208-4011-8585-69669a829844
July 06, 2018
3
September 24, 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)

[?]
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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