telli health

GUDID 06939184630090

Blood Glucose Meter

Bioland Technology Ltd.

Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use

• Primary Device ID: 06939184630090
• NIH Device Record Key: 93ff75ce-0cee-4af4-b24c-78e8d0e2fc99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: telli health
• 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	06939184630090 [Primary]

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: 2021-03-15
• Device Publish Date: 2021-03-06

On-Brand Devices [telli health]

• 06939184630090: Blood Glucose Meter
• 06939184600192: Blood Glucose Test strips
• 00693918463021: Blood Glucose Monitoring System, It contains blood glucose meter, blood glucose test strips, lan
• 06939184630212: Blood Glucose Monitoring System, It contains blood glucose meter, blood glucose test strips, lan