DEVICE: CardioChek® analyzer (00381931709010)

Device Identifier (DI) Information

CardioChek® analyzer
1709
In Commercial Distribution
1709
POLYMER TECHNOLOGY SYSTEMS, INC.
00381931709010
GS1

1
835772872 *Terms of Use
The CardioChek® analyzer is intended for in vitro diagnostic use to test whole blood. The specific analyte measured is determined by the type of test strip chosen.
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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, home-use, battery-powered A portable, battery-powered instrument intended to be used by a layperson in the home or similar environment 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
LBR LDL & VLDL PRECIPITATION, HDL
NBW SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
NGO TEST, TRIGLYCERIDES, OVER THE COUNTER
JGY COLORIMETRIC METHOD, TRIGLYCERIDES
NAQ LIPOPROTEIN, HIGH DENSITY, HDL, OVER THE COUNTER
CHH ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL
CGA GLUCOSE OXIDASE, GLUCOSE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K014099 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: Keep dry.
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Special Storage Condition, Specify: Keep away from sunlight.
Storage Environment Temperature: between 10 and 40 Degrees Celsius
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

91d7984a-ce4a-4226-acea-aec1f42d63a4
July 06, 2018
3
July 15, 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)

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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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+1(888)870-5610
customerservice@ptsdiagnostics.com
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