LipidPlus® Meter

Basic Information

• Brand Name: LipidPlus® Meter
• Primary DI: 10763924550507
• Version / Model: MD550
• Company Name: JANT PHARMACAL CORPORATION
• Labeler DUNS: 797393659
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-16
• Public Version: 4
• Public Version Date: 2019-11-27
• Public Version Status: Update
• Public Device Record Key: 9162d105-0f41-4cbc-a103-a37397979360

Device Description

Lipid and Glucose Measuring System

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: Yes
• 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
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	862.1660	1
LBR	Ldl & Vldl Precipitation, Hdl	Clinical Chemistry	862.1475	1
JGY	Colorimetric Method, Triglycerides	Clinical Chemistry	862.1705	1
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

GMDN Terms

Code	Name	Definition	Implantable	Status
62205	Glycated haemoglobin (HbA1c) monitoring system IVD, home-use	A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, and/or other associated disposable materials (e.g., lancet) intended to be used for the quantitative measurement of glycated haemoglobin (HbA1c) 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. The measurement is typically based on an immunological method (e.g., immunoassay) and/or spectrophotometry, and is used to evaluate the long-term control of blood glucose concentration, primarily in persons with diabetes mellitus.	No	Active
62206	Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care	A collection of devices including a portable, electrically-powered, semi-automated or automated instrument (meter), reagents, and/or other associated disposable materials (e.g., lancet) intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glycated haemoglobin (HbA1c) in a whole blood clinical specimen. The measurement is typically based on an immunological method (e.g., immunoassay) and/or spectrophotometry, and is used to evaluate the long-term control of blood glucose concentration, primarily in persons with diabetes mellitus.	No	Active
58168	Home-use/point-of-care blood glucose/ketone monitoring system IVD	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 testing, either at the point-of-care or in self-testing by a layperson, for the quantitative measurement of glucose and ketones in a whole blood clinical specimen. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10763924550507	GS1

Premarket Submissions

Submission Number	Supplement Number
K130295	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 64 – 86 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity