Lucidplus B-Ketone Test Strips 50 count

GUDID 00851225008025

VIDAN DIAGNOSTICS LLC

Ketone (acetoacetate) IVD, reagent

• Primary Device ID: 00851225008025
• NIH Device Record Key: 2d475d8f-835a-4e44-8582-54401dfe7c50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lucidplus B-Ketone Test Strips 50 count
• Version Model Number: 3100-050
• 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: 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	00851225008025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161738

FDA Product Code

• JIN: Nitroprusside, Ketones (Urinary, Non-Quant.)

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: 2019-01-07
• Device Publish Date: 2018-12-06

Devices Manufactured by VIDAN DIAGNOSTICS LLC

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