bioland

GUDID 16939184600939

Glucose Control Solution

Bioland Technology Ltd.

Glucose analyser IVD, home-use

• Primary Device ID: 16939184600939
• NIH Device Record Key: 3977ea3d-9d79-42ca-87f2-106918c73ddd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: bioland
• Version Model Number: A1
• 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	06939184600932 [Primary]
GS1	16939184600939 [Package]; Contains: 06939184600932; Package: [20 Units]; In Commercial Distribution
GS1	26939184600936 [Package]; 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: 2023-02-23
• Device Publish Date: 2023-02-15

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