CardioChek Plus Home Self-Test Analyzer

Basic Information

• Brand Name: CardioChek Plus Home Self-Test Analyzer
• Primary DI: 00381934750019
• Version / Model: 4750
• Catalog Number: 4750
• Company Name: POLYMER TECHNOLOGY SYSTEMS, INC.
• Labeler DUNS: 835772872
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-11
• Public Version: 4
• Public Version Date: 2023-10-18
• Public Version Status: Update
• Public Device Record Key: 9b5c173d-e7e0-4ac4-8e3f-2eecd949f876

Device Description

The CardioChek® Plus Home Self-Test analyzer is intended for self-testing in lay users. It is intended to be used by a single person and should not be shared. The CardioChek® Plus Home Self-Test analyzer is for in vitro diagnostic use to test whole blood from the fingertip. The specific analyte measured is determined by the type of test strip chosen.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

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

GMDN Terms

Code	Name	Definition	Implantable	Status
62181	Multiple clinical chemistry analyser IVD, point-of-care	A portable, electrically-powered instrument intended to be used by health professionals at the point-of-care for the qualitative and/or quantitative in vitro detection of multiple clinical chemistry analytes in a clinical specimen, using one or more technology(ies) [e.g., microfluidics, electrometry, spectrophotometry, colorimetry, fluorimetry, radiometry, chemiluminescence]. Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00381934750019	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 20 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 50 – 104 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight.
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry.