CURO L5 Total Cholesterol Strips

Basic Information

• Brand Name: CURO L5 Total Cholesterol Strips
• Primary DI: 00860394001256
• Version / Model: CURO L5 Total Cholesterol Strips
• Company Name: KPI HEALTHCARE, INC.
• Labeler DUNS: 087243403
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2019-04-26
• Public Version: 4
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: 3bd9e660-1303-4115-8589-7ce543467690

Device Description

Total Cholesterol Strips

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	862.1345	2
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	862.1345	2
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	862.1175	1
JGY	Colorimetric Method, Triglycerides	Clinical Chemistry	862.1705	1
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	862.1660	1
LBR	Ldl & Vldl Precipitation, Hdl	Clinical Chemistry	862.1475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62792	Glucose/ketone/lipid monitoring system IVD, home-use	A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories [e.g., control solutions, lancets] intended to be used together for the quantitative measurement of glucose, ketones, and a lipid(s) [e.g., cholesterol] in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.	No	Obsolete
64125	Multiple physiological parameter spot-check system analyser	An electrically-powered device intended to be used exclusively at the point-of-care by medical professionals to spot-check (user-initiated) measure and record multiple physiological and biological parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure and haemoglobin oxygen saturation (SpO2), blood glucose, blood cholesterol]. It consists of a portable electronic unit intended to be used with noninvasive devices [not included] (e.g., blood pressure cuff, ECG leads) and rapid test strips; measured data is typically wirelessly sent to a phone/tablet device with software for viewing.	No	Active
62538	Glucose monitoring system IVD, point-of-care	A collection of devices including a portable, electrically-powered instrument (meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glucose singularly in a whole blood clinical specimen. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.	No	Active
62646	Glucose analyser IVD, point-of-care	An electrically-powered instrument intended to be used exclusively at the point-of-care by medical professionals for the quantitative in vitro measurement of glucose levels in whole blood. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus. This analyser is typically included in a blood glucose monitoring system.	No	Active
56686	Glucose analyser IVD, laboratory, automated/semi-automated	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the quantitative in vitro measurement of glucose levels in whole blood, serum, plasma and/or other body fluid.	No	Active
62739	Glucose analyser IVD, laboratory, manual	An electrically-powered manual laboratory instrument intended to be used for the quantitative in vitro measurement of glucose levels in whole blood, serum, plasma and/or other body fluid.	No	Active
44206	Glucose analyser IVD, laboratory, automated	A mains electricity (AC-powered) laboratory instrument intended to be used for the quantitative in vitro measurement of glucose levels in whole blood, serum, plasma and/or other body fluid. The device operates with minimal technician involvement and complete automation of all procedural steps.	No	Obsolete
62645	Glucose analyser IVD, home-use	An electrically-powered instrument intended to be used for the quantitative in vitro measurement of glucose levels in whole blood; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus. This analyser is typically included in a blood glucose monitoring system.	No	Active
63088	Blood glucose/blood pressure monitoring system, point-of-care	A collection of devices intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glucose levels in whole blood in a short period, typically several minutes, and to noninvasively measure blood pressure. It typically consists of a portable analyser (a self-testing meter), reagents, test strips and accessories (e.g., a lancet), and a blood pressure cuff. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.	No	Active
62537	Glucose monitoring system IVD, home-use	A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.	No	Active
63087	Blood glucose/blood pressure monitoring system, home-use	A collection of devices intended for the quantitative measurement of glucose levels in whole blood in a short period, typically several minutes, and to noninvasively measure blood pressure; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. It typically consists of a portable analyser (a self-testing meter), reagents, test strips and accessories (e.g., a lancet), and a blood pressure cuff. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.	No	Active
60770	Ambulatory insulin infusion pump/interstitial glucose monitoring system	An assembly of portable devices intended to simultaneously continuously monitor interstitial glucose levels and subcutaneously infuse insulin in patients with diabetes. Sometimes referred to as a closed loop artificial pancreas, it consists of a percutaneous blood glucose monitoring system (CGM), an ambulatory insulin infusion pump, and software on a dedicated handset or transmitter capable of telemetric communication with the other components. The software contains an algorithm to allow continuous communication between the two devices, and may enable the manual input of data with respect to meals and physical activity.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860394001256	GS1
Unit of Use	00860394001218	GS1

Premarket Submissions

Submission Number	Supplement Number
K130295	000