LucidPlus B-Ketone Plus Blood Glucose Monitoring System

GUDID 00851225008001

VIDAN DIAGNOSTICS LLC

Multiple clinical chemistry analyte monitoring system IVD, point-of-care

• Primary Device ID: 00851225008001
• NIH Device Record Key: 831cff4b-e8f7-4f74-b534-d851ae81387c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LucidPlus B-Ketone Plus Blood Glucose Monitoring System
• Version Model Number: 300300
• Company DUNS: 092729952
• Company Name: VIDAN DIAGNOSTICS LLC
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851225008001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161738

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: 2019-12-11
• Device Publish Date: 2018-11-27

Devices Manufactured by VIDAN DIAGNOSTICS LLC

• 00851225008001 - LucidPlus B-Ketone Plus Blood Glucose Monitoring System: 2019-12-11
• 00851225008001 - LucidPlus B-Ketone Plus Blood Glucose Monitoring System: 2019-12-11
• 00851225008025 - Lucidplus B-Ketone Test Strips 50 count: 2019-01-07
• 00851225008032 - Lucidplus Glucose Test strips 50 count: 2019-01-04