DEVICE: Henry Schein (00304040002575)

Device Identifier (DI) Information

Henry Schein
9004994
In Commercial Distribution
9004994
HENRY SCHEIN, INC.
00304040002575
GS1

1
012430880 *Terms of Use
Urispec 10SG Urine Strip
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Device Characteristics

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

GMDN

[?]

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, kit, colorimetric dipstick, rapid A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative screening of urine for multiple analytes within a short period relative to standard laboratory testing procedures, using a colorimetric dipstick method. This test is commonly used in the laboratory or in point-of-care analyses.
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FDA Product Code

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Product Code Product Code Name
JMT DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT)
CDM DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)
JIN NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)
JRE REFRACTOMETER FOR CLINICAL USE
JIL METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)
JJB AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.)
JIO BLOOD, OCCULT, COLORIMETRIC, IN URINE
CEN DYE-INDICATOR, PH (URINARY, NON-QUANT.)
JJR ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED)
LJX TEST, URINE LEUKOCYTE
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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

[?]
Storage and Handling
Special Storage Condition, Specify: Store out of direct sunlight. Open bottles should be used within 3 months after first openning.
Storage Environment Temperature: between 15 and 30 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

e0de83f9-7075-4a32-be42-2c7005634dd0
March 29, 2018
2
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
10304040002572 24 00304040002575 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
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(732)918-0770
technical@immunostics.com
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