BioHermes A1C EZ 2.0 Glycohemoglobin Analyzer A1C-M21

GUDID 16935784410008

A1C EZ 2.0 Glycohemoglobin Analyzer is intended to be used for testing glycohemoglobin concentration as anaid to monitor the risk of developing diabetes and control the status of diabetes.The HbA1c analyzer is specifically designed to be used with the corresponding test strip.

Wuxi Biohermes Bio & Medical Technology Co.,Ltd.

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• Primary Device ID: 16935784410008
• NIH Device Record Key: 385eba8a-9931-4e4b-948a-b24d2da24e1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioHermes A1C EZ 2.0 Glycohemoglobin Analyzer
• Version Model Number: A1C EZ 2.0
• Catalog Number: A1C-M21
• 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	06935784410001 [Primary]
GS1	16935784410008 [Package]; Contains: 06935784410001; Package: box [24 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 A1C EZ 2.0 Glycohemoglobin Analyzer ]

• 06935784400019: A1C EZ 2.0 Glycohemoglobin Analyzer is intended to be used for testing glycohemoglobin concentra
• 16935784410008: A1C EZ 2.0 Glycohemoglobin Analyzer is intended to be used for testing glycohemoglobin concentra