BioHermes GluCoA1c Blood Glucose Test Strips

Basic Information

• Brand Name: BioHermes GluCoA1c Blood Glucose Test Strips
• Primary DI: 06935784400057
• Version / Model: GLU-A1C S04
• Catalog Number: GLU-S22
• 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: fc297b54-f51c-47f7-963e-327e15d3c5ac

Device Description

GluCoA1c Blood Glucose Test Strips, 50 Tests/Kit. Intended use: The GluCoA1c blood glucose test strips are for use with the GluCoA1c analyzer to quantitatively measure the glucose level of fresh capillary whole blood. Contents: 50 test strips; package insert.

Device Characteristics

• Single Use: Yes
• 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: No
• 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
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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06935784400057	GS1
Package	16935784400054	GS1	box	120	In Commercial Distribution