BioHermes GluCoA1c Blood Glucose Test Strips GLU-S22

GUDID 06935784400057

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.

Wuxi Biohermes Bio & Medical Technology Co.,Ltd.

Glucose IVD, kit, electrometry

• Primary Device ID: 06935784400057
• NIH Device Record Key: fc297b54-f51c-47f7-963e-327e15d3c5ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioHermes GluCoA1c Blood Glucose Test Strips
• Version Model Number: GLU-A1C S04
• Catalog Number: GLU-S22
• 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: true
• Lot Batch: true
• Serial Number: false
• 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	06935784400057 [Primary]
GS1	16935784400054 [Package]; Package: box [120 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: 2021-06-02
• Device Publish Date: 2021-05-25

On-Brand Devices [BioHermes GluCoA1c Blood Glucose Test Strips]

• 06935784420055: GluCoA1c Blood Glucose Test Strips, 50 Tests/Kit. Intended use: The GluCoA1c blood glucose test
• 06935784400057: GluCoA1c Blood Glucose Test Strips, 50 Tests/Kit. Intended use: The GluCoA1c blood glucose tes