GlucoseLeader Enhance Blood Glucose Monitoring System(BR/VM)

Basic Information

• Brand Name: GlucoseLeader Enhance Blood Glucose Monitoring System(BR/VM)
• Primary DI: 04711200722451
• Version / Model: 3K-01-14010B
• Catalog Number: 3K-01-14010B
• Company Name: HMD BIOMEDICAL INC.
• Labeler DUNS: 658644174
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-20
• Public Version: 1
• Public Version Date: 2020-05-28
• Public Version Status: New
• Public Device Record Key: f548dd91-d5b1-4d14-b41c-cd71f09152d8

Device Description

GlucoseLeader Enhance P5 Blood Glucose Monitoring System(BR/VM)

Device Characteristics

• Single Use: Yes
• 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: 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

GMDN Terms

Code	Name	Definition	Implantable	Status
53303	Glucose IVD, kit, electrometry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method.	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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04711200722451	GS1
Package	00389154000914	GS1	KIT	60	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K182428	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 8 – 44 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 46.6 – 111.2 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 10 – 70 Percent (%) Relative Humidity