ODM 99GM291I01

GUDID 00883489001504

The combination products includes 1 pce of lancing device_GD500(00883489001566), 1 pc of control solution(00883489001580),10 pcs/set of lancet(Sterile)(00883489001597) and 10 pcs/vial of strips_iGlucose Strip(00883489001573).

BIONIME CORPORATION

Glucose monitoring system IVD, home-use

• Primary Device ID: 00883489001504
• NIH Device Record Key: 24bd8864-462f-451d-80ea-dc478ffab99e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ODM
• Version Model Number: iGlucose Blood Glucose Monitoring System
• Catalog Number: 99GM291I01
• 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: true
• Single Use: true
• 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

Customer Support Contacts

• Phone: 1-844-445-8267
• Email: support@iglucose.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883489001504 [Primary]
GS1	00883489001511 [Package]; Package: box [1 Units]; In Commercial Distribution
GS1	00883489001566 [Package]; Package: combo [1 Units]; In Commercial Distribution
GS1	00883489001573 [Package]; Package: combo [10 Units]; In Commercial Distribution
GS1	00883489001580 [Package]; Package: combo [1 Units]; In Commercial Distribution
GS1	00883489001597 [Package]; Package: combo [10 Units]; In Commercial Distribution
GS1	10883489001518 [Package]; Contains: 00883489001511; Package: paper box [6 Units]; In Commercial Distribution
GS1	20883489001508 [Package]; Contains: 10883489001518; Package: paper carton [8 Units]; In Commercial Distribution
GS1	20883489001515 [Package]; Contains: 00883489001511; Package: carton [40 Units]; Discontinued: 2020-01-03; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161790

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-06
• Device Publish Date: 2017-07-19

On-Brand Devices [ODM]

• 00883489001542: iGlucose test strips
• 00883489001504: The combination products includes 1 pce of lancing device_GD500(00883489001566), 1 pc of control
• 20883489002420: 25 strips - 80883489002415
• 00883489002396: 1 meter - 00883489002396
• 20883489002383: 1 meter - 00883489002372