DEVICE: Henry Schein (00304040001462)

Device Identifier (DI) Information

Henry Schein
9007507
In Commercial Distribution
9007507
HENRY SCHEIN, INC.
00304040001462
GS1

1
012430880 *Terms of Use
Urispec + UA Reader w 12 Promo
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Device Characteristics

MR Safe
No
Yes
Yes
Yes
No
Yes
Yes
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.
Urine analyser IVD, laboratory, semi-automated A mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of various chemical and cellular constituents of a clinical urine specimen, which typically include bilirubin, glucose, haemoglobin, ketones, nitrites, pH, protein, urobilinogen, specific gravity, blood, red cells, white cells, casts, crystals, sperm, and/or microorganisms (e.g., bacteria). The device uses technology which may include electrical impedance, conductivity, enzyme spectrophotometry, nephelometry and/or photometry. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.
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FDA Product Code

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Product Code Product Code Name
JJB AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.)
JIP BLOOD, OCCULT, ENZYMATIC METHOD, IN URINE
CDM DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)
CEN DYE-INDICATOR, PH (URINARY, NON-QUANT.)
JIN NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)
JIL METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)
LJX TEST, URINE LEUKOCYTE
JMA ACID, ASCORBIC, 2,4-DINITROPHENYLHYDRAZINE (SPECTROPHOTOMETRIC)
JMT DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT)
JIR INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)
KQO AUTOMATED URINALYSIS SYSTEM
KSL SOLUTION, COPPER SULFATE FOR SPECIFIC GRAVITY DETERMINATIONS
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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
Storage Environment Temperature: between 4 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

ca36ec45-17a0-450d-8077-701f2f3d7d1f
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
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
Yes
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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