AccessGUDID - DEVICE: CardioChek Plus Home Lipid Panel Self-Test Strip 2ct (00381934722016)

GUDID

Device Identifier (DI) Information

Brand Name: CardioChek Plus Home Lipid Panel Self-Test Strip 2ct
Version or Model: 4722
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4722
Company Name: POLYMER TECHNOLOGY SYSTEMS, INC.

Primary DI Number: 00381934722016
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 835772872 *Terms of Use

Device Description: CardioChek® Plus Home Lipid Panel Self-Test test strips are in vitro diagnostic devices used to measure total cholesterol, HDL cholesterol, and triglycerides levels in human whole blood from the fingertip, as well as providing a calculated value for LDL levels. These test strips must be used in conjunction with a CardioChek® PA, CardioChek Plus or CardioChek Plus Home Self-Test 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):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
53354	Multiple lipid analyte IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple lipid analytes [e.g., total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL)] to generate a lipid profile of a clinical specimen, using a spectrophotometry method. Some types may also detect additional analytes (e.g., glucose, ketones, uric acid).	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151545	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

[?]

Storage and Handling
Special Storage Condition, Specify: Keep away from sunlight.
Special Storage Condition, Specify: Keep dry.
Storage Environment Temperature: between 20 and 30 Degrees Celsius
Storage Environment Temperature: between 68 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 89163705-7d4c-4739-be46-b348eb52514b
Public Version Date: July 06, 2023
Public Version Number: 4
DI Record Publish Date: February 08, 2021