Sibel

GUDID 06939184626079

Blood Pressure Monitor

Bioland Technology Ltd.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 06939184626079
• NIH Device Record Key: 16c41088-6202-416a-b716-23bf5776744f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sibel
• Version Model Number: 2006-2B
• Company DUNS: 545852548
• Company Name: Bioland Technology Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	06939184626079 [Primary]
GS1	16939184626076 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201467

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

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: 2022-04-11
• Device Publish Date: 2022-04-03

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