RIGHTEST GT333 Blood Glucose Test Strip

GUDID 20883489001911

BIONIME CORPORATION

Glucose monitoring system IVD, home-use

• Primary Device ID: 20883489001911
• NIH Device Record Key: e1bf6ef8-e77a-49a5-8140-ca2950221e74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIGHTEST GT333 Blood Glucose Test Strip
• Version Model Number: 100PCS
• 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: false
• 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: 1 909 781 6969
• Email: info@bionimeusa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883489001900 [Primary]
GS1	00883489001917 [Package]; Contains: 00883489001900; Package: paper [4 Units]; In Commercial Distribution
GS1	10883489001914 [Package]; Contains: 00883489001917; Package: paper [12 Units]; In Commercial Distribution
GS1	20883489001911 [Package]; Contains: 10883489001914; Package: paper [12 Units]; In Commercial Distribution
GS1	80883489001906 [Unit of Use]

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: 2019-10-16
• Device Publish Date: 2019-10-08

On-Brand Devices [RIGHTEST GT333 Blood Glucose Test Strip]

• 20883489001911: 100PCS
• 20883489001898: 50 PCS
• 20883489001874: 25pcs