DEVICE: CardioChek Plus Lipid + eGLU Test Strips Smart Bundle™ (2-pk) (00381932729017)

Device Identifier (DI) Information

CardioChek Plus Lipid + eGLU Test Strips Smart Bundle™ (2-pk)
2729
In Commercial Distribution
2729
POLYMER TECHNOLOGY SYSTEMS, INC.
00381932729017
GS1

15
835772872 *Terms of Use
CardioChek Plus Lipid + eGLU Test Strips Smart Bundle™ are in vitro diagnostic devices used to monitor glucose and lipid (total cholesterol / HDL cholesterol / and triglyceride) levels in human whole blood. These test strips must be used in conjunction with a CardioChek Plus analyzer.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
Yes
Yes
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 clinical chemistry enzyme IVD, kit, enzyme spectrophotometry A collection of reagents and other associated materials intended to be used for the quantitative measurement of one or multiple clinical chemistry enzymes using an enzyme spectrophotometry method.
Glucose/ketone/lipid profile IVD, kit, multiple technologies A collection of reagents and other associated materials intended to be used together to produce a profile consisting of one or multiple clinical chemistry analytes which may include glucose, ketones and/or a lipid profile, using a number of different technologies on a single analyser.
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FDA Product Code

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

FDA Premarket Submission Number [?] Supplement Number [?]
K022898 000
K023558 000
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 68 and 86 Degrees Fahrenheit
Special Storage Condition, Specify: Keep dry.
Storage Environment Temperature: between 20 and 30 Degrees Celsius
Special Storage Condition, Specify: Keep away from sunlight.
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

fdcb6735-9a33-4208-8714-6783156507d0
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: 10381932729014 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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