BioHermes Limpid Blood Glucose Meter

Basic Information

• Brand Name: BioHermes Limpid Blood Glucose Meter
• Primary DI: 06935784450007
• Version / Model: GM 1.0
• Catalog Number: GLU-M11
• Company Name: Wuxi Biohermes Bio & Medical Technology Co.,Ltd.
• Labeler DUNS: 528192913
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-25
• Public Version: 2
• Public Version Date: 2021-11-03
• Public Version Status: Update
• Public Device Record Key: 43bda7ac-c8ff-4c2c-a097-ce5125b0d7e3

Device Description

Limpid Blood Glucose Meter is for use with Limpid Blood Glucose Test Strips to quantitatively measure the glucose level of fresh capillary whole blood. This product is for in vitro diagnostics only, which means only for use outside the body.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
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
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
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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06935784450007	GS1
Package	16935784450004	GS1	box	18	In Commercial Distribution