GE

GUDID 20883489001348

BIONIME CORPORATION

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

• Primary Device ID: 20883489001348
• NIH Device Record Key: 5a698f47-f50a-4a59-8dbc-849dc4d8e85f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GE
• Version Model Number: GE100 Control Solution
• 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: 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	00883489001337 [Primary]
GS1	00883489001344 [Package]; Contains: 00883489001337; Package: box [1 Units]; In Commercial Distribution
GS1	10883489001341 [Package]; Contains: 00883489001344; Package: case [120 Units]; In Commercial Distribution
GS1	20883489001348 [Package]; Contains: 10883489001341; Package: carton [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092052

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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: 2016-12-15

On-Brand Devices [GE]

• 00883489310309: GE100
• 20883489001744: One box with 2 vials strip
• 20883489001720: 1 meter -00883489001719 1 vial of 10 pcs strip -00883489001757 1 lancing device -00883489001771
• 00883489001719: meter
• 20883489001706: 333
• 00883489001689: strip vial
• 10883489001662: 333
• 00883489001641: meter
• 00883489001443: GE100 Control Solution
• 00883489001436: GE100 Control Solution
• 00883489001399: GE100
• 20883489001386: GS550
• 20883489001362: GE100
• 20883489001348: GE100 Control Solution
• 20883489001287: GE100
• 20883489001263: GE100
• 20883489001249: GE100
• 20883489001225: GE100
• 20883489001201: GE100
• 00883489001177: GE100
• 20883489001485: GP200
• 20883489001829: GE333 control solution (High level)
• 20883489001805: GE333 control solution(Normal Level)
• 00883489001320: GE Lancing device
• 00883489002563: Kitbox