DEVICE: PTS Panels® Ketones Test Strips (00381931718012)

Device Identifier (DI) Information

PTS Panels® Ketones Test Strips
1718
Not in Commercial Distribution
1718
POLYMER TECHNOLOGY SYSTEMS, INC.
00381931718012
GS1
January 20, 2017
25
835772872 *Terms of Use
PTS Panels® Ketone Test Strips are in vitro diagnostic devices used to monitor ketone levels in human whole blood. These test strips must be used in conjunction with a CardioChek or CardioChek PA analyzer.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
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
Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry 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 an enzyme spectrophotometry method.
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FDA Product Code

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Product Code Product Code Name
JMK ACID, ALPHA-KETOBUTYRIC AND NADH (U.V.), HYDROXYBUTYRIC DEHYDROGENASE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K981865 000
K983860 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 away from sunlight.
Storage Environment Temperature: between 20 and 30 Degrees Celsius
Special Storage Condition, Specify: Keep dry.
Storage Environment Temperature: between 68 and 86 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

df50c36b-adf2-4b1c-82b9-f240fe1fc1d8
July 06, 2018
3
September 08, 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: 10381931718019 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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