iGlucose Touch Blood Glucose Meter

GUDID 00883489002662

BIONIME CORPORATION

Glucose monitoring system IVD, home-use

• Primary Device ID: 00883489002662
• NIH Device Record Key: c19a0302-4869-4038-9223-9dabc5cc5f4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iGlucose Touch Blood Glucose Meter
• Version Model Number: iGlucose Touch
• Company DUNS: 658637244
• Company Name: BIONIME CORPORATION
• Device Count: 1
• DM Exempt: false
• 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883489002655 [Primary]
GS1	00883489002662 [Package]; Contains: 00883489002655; Package: paper box [1 Units]; In Commercial Distribution
GS1	10883489002669 [Package]; Package: internal carton [10 Units]; In Commercial Distribution
GS1	20883489002666 [Package]; Contains: 10883489002669; Package: carton [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240637

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: 2025-12-12
• Device Publish Date: 2025-12-04

Devices Manufactured by BIONIME CORPORATION

• 00883489002662 - iGlucose Touch Blood Glucose Meter: 2025-12-12
• 00883489002662 - iGlucose Touch Blood Glucose Meter: 2025-12-12
• 00883489002686 - iGlucose Touch Blood Glucose Test Strip: 2025-12-12
• 00883489002709 - iGlucose Touch Control Solution: 2025-12-12 Level 2*1 bottle
• 00883489002563 - GE: 2024-10-29 Kitbox
• 00883489002525 - SMARTMETER: 2024-01-26 kit only has one meter
• 00883489002501 - SMARTMETER: 2023-12-25 Control Solution-Level 2
• 00883489001306 - RIGHTEST: 2023-07-11 single lancing device
• 00883489001320 - GE: 2023-07-11 GE Lancing device