BioHermes GluCoA1c Blood Glucose and Glycohemoglobin Analyzer GCA-M31

GUDID 16935784420250

GluCoA1c Blood Glucose and Glycohemoglobin Analyzer. Intended use: GluCoA1c analyzer is for use with GluCoA1c Glycohemoglobin Test Kit and GluCoA1c Blood Glucose Test Strips to quantitatively measure the HbA1c in human capillary blood or venous blood,and the blood glucose in human capillary blood.

Wuxi Biohermes Bio & Medical Technology Co.,Ltd.

Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care

• Primary Device ID: 16935784420250
• NIH Device Record Key: 1284fc52-bb36-46cc-b39d-dbd5c3ed38e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioHermes GluCoA1c Blood Glucose and Glycohemoglobin Analyzer
• Version Model Number: GLU-A1C M14
• Catalog Number: GCA-M31
• Company DUNS: 528192913
• Company Name: Wuxi Biohermes Bio & Medical Technology Co.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06935784420253 [Primary]
GS1	16935784420250 [Package]; Contains: 06935784420253; Package: box [18 Units]; In Commercial Distribution

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-05
• Device Publish Date: 2022-08-26

On-Brand Devices [BioHermes GluCoA1c Blood Glucose and Glycohemoglobin Analyzer]

• 06935784420246: GluCoA1c Blood Glucose and Glycohemoglobin Analyzer. Intended use: GluCoA1c analyzer is for use
• 06935784420239: GluCoA1c Blood Glucose and Glycohemoglobin Analyzer. Intended use: GluCoA1c analyzer is for use
• 16935784420267: GluCoA1c Blood Glucose and Glycohemoglobin Analyzer. Intended use: GluCoA1c analyzer is for use
• 16935784420250: GluCoA1c Blood Glucose and Glycohemoglobin Analyzer. Intended use: GluCoA1c analyzer is for use