DKK

GUDID 16939184627103

Blood glucose monitoring system, it contains blood glucose meter, blood glucose test strips, lancing device and sterile lancet.

Bioland Technology Ltd.

Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use

• Primary Device ID: 16939184627103
• NIH Device Record Key: 27b4174c-f5e6-4b47-a0bf-6ba0c537d1a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DKK
• 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: 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06939184627106 [Primary]
GS1	16939184627103 [Package]; Contains: 06939184627106; Package: [10 Units]; In Commercial Distribution
GS1	26939184627100 [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: 2021-07-26
• Device Publish Date: 2021-07-16

Devices Manufactured by Bioland Technology Ltd.

• 16939184642526 - Bioland: 2024-04-03 Bioland G-425-2 Blood Glucose Monitoring System
• 16939184601356 - Glucoracy: 2024-04-02 Glucoracy G-425-2S Blood Glucose Test Strips
• 16939184610723 - INSMART: 2023-11-09 Blood Pressure Monitor
• 16939184600946 - Glucoracy: 2023-10-16 Glucoracy GLUCOSE CONTROL SOLUTION
• 16939184630899 - Glucoracy: 2023-10-16 Glucoracy G-427B Blood Glucose Monitoring System
• 16939184630882 - Glucoracy: 2023-09-27 Glucoracy G-425-2 Blood Glucose Monitoring System
• 16939184600359 - ELERA: 2023-08-23 Blood Glucose Test Strips
• 16939184600489 - Glucoracy: 2023-08-23 Glucoracy G-425-2S Blood Glucose Test Strips