AccessGUDID - DEVICE: ChekMate™ Strips (00381930860019)

GUDID

Device Identifier (DI) Information

Brand Name: ChekMate™ Strips
Version or Model: 860
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 860
Company Name: POLYMER TECHNOLOGY SYSTEMS, INC.

Primary DI Number: 00381930860019
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 835772872 *Terms of Use

Device Description: ChekMate™ Strips are dry strips that mimic the use of the PTS Panels test strips to check the CardioChek analyzer system optics, calibration, and result handling algorithms.

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
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, calibrator	A material which is used to establish known points of reference for a number of assays 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.

FDA Product Code

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Product Code	Product Code Name
CHH	ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL
CGA	GLUCOSE OXIDASE, GLUCOSE
LBR	LDL & VLDL PRECIPITATION, HDL
JGY	COLORIMETRIC METHOD, TRIGLYCERIDES

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151530	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: The strips should always be stored in the original container when not in use to protect from light and from accidental scratching.
Special Storage Condition, Specify: Do not expose strips to high humidity, extreme heat, cold, dust or dirt.
Special Storage Condition, Specify: Keep dry.
Storage Environment Temperature: between 68 and 80 Degrees Fahrenheit
Storage Environment Temperature: between 20 and 27 Degrees Celsius
Special Storage Condition, Specify: Keep away from sunlight.
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a6e7d522-4721-4187-96e5-a5c878e0ba94
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 15, 2016