ODM 99GS280D51

GUDID 20883489002420

25 strips - 80883489002415

BIONIME CORPORATION

Glucose monitoring system IVD, home-use

• Primary Device ID: 20883489002420
• NIH Device Record Key: 91b9ca22-783a-4627-8302-57d86d5685ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ODM
• Version Model Number: Diathrive+ Blood Glucose Test Strip
• Catalog Number: 99GS280D51
• Company DUNS: 658637244
• Company Name: BIONIME CORPORATION
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: 866-878-7477
• Email: customerservice@diathrive.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883489002419 [Primary]
GS1	00883489002426 [Package]; Contains: 00883489002419; Package: Box [2 Units]; In Commercial Distribution
GS1	10883489002423 [Package]; Contains: 00883489002426; Package: Box [20 Units]; In Commercial Distribution
GS1	20883489002420 [Package]; Contains: 10883489002423; Package: Box [12 Units]; In Commercial Distribution
GS1	80883489002415 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170143

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: 2020-01-27
• Device Publish Date: 2020-01-17

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