CardioChek

Basic Information

• Brand Name: CardioChek
• Primary DI: 10304040037741
• Version / Model: 5700414
• Catalog Number: 5700414
• Company Name: HENRY SCHEIN, INC.
• Labeler DUNS: 012430880
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 15
• Record Status: Published
• Publish Date: 2017-01-05
• Public Version: 5
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: fb04be17-469f-4e0d-a436-1b97e3b72731

Device Description

CardioChek Lipid Panel Test

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• Kit: No
• 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
LBR	LDL & VLDL PRECIPITATION, HDL	Clinical Chemistry	862.1475	1
CHH	ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL	Clinical Chemistry	862.1175	1
JGY	COLORIMETRIC METHOD, TRIGLYCERIDES	Clinical Chemistry	862.1705	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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10304040037741	GS1
Unit of Use	00304040037744	GS1

Premarket Submissions

Submission Number	Supplement Number
K022898	000
K023558	000

Storage Conditions

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