Glucoracy

GUDID 16939184600946

Glucoracy GLUCOSE CONTROL SOLUTION

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

• Primary Device ID: 16939184600946
• NIH Device Record Key: 0d163d1a-0f75-4952-bcf0-1363465ca85f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Glucoracy
• Version Model Number: LEVEL 2
• 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06939184600949 [Primary]
GS1	16939184600946 [Package]; Contains: 06939184600949; Package: [1 Units]; In Commercial Distribution
GS1	26939184600943 [Package]; Package: [500 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202739

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: 2023-10-16
• Device Publish Date: 2023-10-07

On-Brand Devices [Glucoracy]

• 06939184630670: Glucoracy G-425-2 Blood Glucose Monitoring System
• 16939184600694: Glucoracy G-425-2S Blood Glucose Test Strips
• 16939184600496: Glucoracy G-425-2S Blood Glucose Test Strips
• 16939184600489: Glucoracy G-425-2S Blood Glucose Test Strips
• 16939184630882: Glucoracy G-425-2 Blood Glucose Monitoring System
• 16939184630899: Glucoracy G-427B Blood Glucose Monitoring System
• 16939184600946: Glucoracy GLUCOSE CONTROL SOLUTION
• 16939184601356: Glucoracy G-425-2S Blood Glucose Test Strips