Wellue

GUDID 16934440100000

Blood Glucose Meter

Bioland Technology Ltd.

Glucose analyser IVD, home-use

• Primary Device ID: 16934440100000
• NIH Device Record Key: cb428e9a-15c8-452d-8c9b-084883c8040b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wellue
• Version Model Number: G-427B
• Company DUNS: 545852548
• Company Name: Bioland Technology Ltd.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06934440101093 [Primary]
GS1	16934440100000 [Package]; Contains: 06934440101093; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191657

FDA Product Code

• NBW: System, Test, Blood Glucose, Over The Counter

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: 2021-01-28
• Device Publish Date: 2021-01-20

On-Brand Devices [Wellue]

• 16934440100017: Blood Glucose Test Strips
• 16934440100000: Blood Glucose Meter