DEVICE: CardioChek (00304040037713)

Device Identifier (DI) Information

CardioChek
5700411
In Commercial Distribution
5700411
HENRY SCHEIN, INC.
00304040037713
GS1

1
012430880 *Terms of Use
CardioChek Plus Analyzer
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
Yes
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
Multichannel clinical chemistry analyser IVD, point-of-care, battery-powered A portable, battery-powered instrument intended to be used by health professionals at the point-of-care to analyse a clinical specimen for the qualitative and/or quantitative determination of multiple clinical chemistry analytes simultaneously from multiple analytical processes. Analytes measured may include electrolytes, specific proteins, lipids, and kidney, liver and/or cardiac function test analytes using two or more technologies which may include microfluidics, electrometry, spectrophotometry, fluorimetry, radiometry and/or chemiluminescence.
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FDA Product Code

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Product Code Product Code Name
CHH ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL
JGY COLORIMETRIC METHOD, TRIGLYCERIDES
LBR LDL & VLDL PRECIPITATION, HDL
NBW SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
CGA GLUCOSE OXIDASE, GLUCOSE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K140068 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
Storage Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Special Storage Condition, Specify: Keep away from sunlight.
Special Storage Condition, Specify: Keep dry.
Storage Environment Temperature: between 50 and 104 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

70e8306b-253e-4eb0-aa8b-8f259464e279
July 06, 2018
3
January 05, 2017
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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)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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