CardioChek Plus Home Lipid + eGLU Smart Bundle Self-Test 2ct

Basic Information

• Brand Name: CardioChek Plus Home Lipid + eGLU Smart Bundle Self-Test 2ct
• Primary DI: 00381934721019
• Version / Model: 4721
• Catalog Number: 4721
• Company Name: POLYMER TECHNOLOGY SYSTEMS, INC.
• Labeler DUNS: 835772872
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2021-02-08
• Public Version: 4
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: 2d32b6ac-c3f0-4d91-adc2-498ea953d0cb

Device Description

CardioChek Plus Home Lipid + eGLU Smart Bundle Self-Test test strips are in vitro diagnostic devices used to measure glucose and lipid (total cholesterol / HDL cholesterol / and triglyceride) levels in human whole blood from the fingertip. These test strips must be used in conjunction with a CardioChek Plus Home Self-Test analyzer.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CGA	GLUCOSE OXIDASE, GLUCOSE	Clinical Chemistry	862.1345	2
JGY	COLORIMETRIC METHOD, TRIGLYCERIDES	Clinical Chemistry	862.1705	1
NBW	System, test, blood glucose, over the counter	Clinical Chemistry	862.1345	2
LBR	LDL & VLDL PRECIPITATION, HDL	Clinical Chemistry	862.1475	1
CHH	ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL	Clinical Chemistry	862.1175	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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).	No	Active
52848	Multiple lipid analyte IVD, kit, multiple technologies	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 produce a lipid profile, using a number of different technologies on a single analyser. Some types may also detect additional analytes (e.g., glucose, ketones, uric acid).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10381934721016	GS1
Primary	00381934721019	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K022898	000
K023558	000
K140068	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry.
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight.
• Type: Storage Environment Temperature
• Temperature Range: 20 – 30 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 68 – 86 Degrees Fahrenheit