AccessGUDID - DEVICE: PTS Panels® Triglycerides Test Strips (00381931716018)

GUDID

Device Identifier (DI) Information

Brand Name: PTS Panels® Triglycerides Test Strips
Version or Model: 1716
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1716
Company Name: POLYMER TECHNOLOGY SYSTEMS, INC.

Primary DI Number: 00381931716018
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 835772872 *Terms of Use

Device Description: PTS Panels® Triglycerides test strips are in vitro diagnostic devices used to monitor triglycerides levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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.

FDA Product Code

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Product Code	Product Code Name
CDT	LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES
JGY	COLORIMETRIC METHOD, TRIGLYCERIDES

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K991894	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d3b9b6fa-7407-4843-b8fe-4d29b4b244ab
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 22, 2016