bioland

GUDID 16939184630073

Blood Glucose Meter

Bioland Technology Ltd.

Glucose analyser IVD, home-use

• Primary Device ID: 16939184630073
• NIH Device Record Key: 9558ef64-71c5-4159-9e75-c8478cb65c6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: bioland
• 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	06939184630076 [Primary]
GS1	16939184630073 [Package]; Contains: 06939184630076; Package: [10 Units]; In Commercial Distribution
GS1	26939184630070 [Package]; Package: [2 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: 2021-01-27
• Device Publish Date: 2021-01-19

On-Brand Devices [bioland]

• 06939184620008: Infrared Thermometer
• 16939184630073: Blood Glucose Meter
• 06939184600178: Blood glucose test strips
• 16939184610082: Blood Pressure Monitor
• 16939184610099: Blood Pressure Monitor
• 16939184600939: Glucose Control Solution
• 06939184600925: Glucose Control Solution
• 06939184600918: Glucose Control Solution
• 06939184600901: Glucose Control Solution
• 16939184642526: Bioland G-425-2 Blood Glucose Monitoring System