Rightest

GUDID 00883489001078

BIONIME CORPORATION

Home-use/point-of-care blood glucose monitoring system IVD

• Primary Device ID: 00883489001078
• NIH Device Record Key: 27689940-8558-4525-ae73-22d1a7f2845c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rightest
• Version Model Number: GS100
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883489001078 [Primary]
GS1	00883489001085 [Package]; Package: box [2 Units]; In Commercial Distribution
GS1	10883489001082 [Package]; Contains: 00883489001085; Package: case [20 Units]; In Commercial Distribution
GS1	20883489001089 [Package]; Contains: 10883489001082; Package: carton [12 Units]; In Commercial Distribution
GS1	80883489001074 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081451

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-14

On-Brand Devices [Rightest]

• 00883489310293: GM250
• 00883489001603: GC300
• 00883489001498: GS100
• 20883489001461: GP200
• 20883489001423: GS100
• 00883489001405: GS300
• 20883489001164: GS550
• 20883489001140: GM550
• 00883489001078: GS100
• 20883489001065: GM100
• 00883489001047: GC300
• 20883489001034: GS300
• 00883489001009: GM300
• 00883489002037: 25 pcs strips(80883489002033) per vial, 2 vials(00883489002037) per box
• 00883489001993: 1 meter - 00883489001986 1 lancing device - 00883489002013 1 control solution -00883489002020
• 00883489001306: single lancing device