CardioChek

Basic Information

• Brand Name: CardioChek
• Primary DI: 00304040040539
• Version / Model: 5700534
• Catalog Number: 5700534
• Company Name: HENRY SCHEIN, INC.
• Labeler DUNS: 012430880
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-16
• Public Version: 9
• Public Version Date: 2023-10-18
• Public Version Status: Update
• Public Device Record Key: c22c60d5-2b27-4e28-9016-e61c6e01d5e0

Device Description

CardioChek Plus Analyzer Starter Pack

Device Characteristics

• Single Use: No
• 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: Yes
• 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
GIO	TUBE, COLLECTION, CAPILLARY BLOOD	Hematology	864.6150	1
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
JJY	Multi-analyte controls, all kinds (assayed)	Clinical Chemistry	862.1660	1
CGA	GLUCOSE OXIDASE, GLUCOSE	Clinical Chemistry	862.1345	2
CHH	ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL	Clinical Chemistry	862.1175	1

GMDN Terms

Code	Name	Definition	Implantable	Status
52900	Multiple clinical chemistry enzyme IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple clinical chemistry enzymes, using a spectrophotometry method. Analytes detected may include alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP).	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
35770	Capillary blood collection tube IVD, no additive	A glass or plastic collection tube containing no additive, intended to be used for the collection, preservation and/or transport of capillary blood for analysis or other investigation (e.g., microhaematocrit, neonatal bilirubin). It is typically sealed at one or both ends with a putty-like substance following specimen collection. This is a single-use device.	No	Active
47869	Multiple-type clinical chemistry analyte profile IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile.	No	Active
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	00304040040539	GS1

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 20 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 68 – 86 Degrees Fahrenheit
• 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