Tyson Bio AC500 Blood Glucose Monitoring System

GUDID 14719869703498

TYSON BIORESEARCH INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 14719869703498
• NIH Device Record Key: 01ef1aeb-c72c-4ecb-a3c0-60b8733c8c36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tyson Bio AC500 Blood Glucose Monitoring System
• Version Model Number: AC500
• Company DUNS: 658026104
• Company Name: TYSON BIORESEARCH INC.
• 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: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719869703491 [Primary]
GS1	14719869703498 [Package]; Contains: 04719869703491; Package: [200 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123087

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: 2020-04-23
• Device Publish Date: 2020-04-15

On-Brand Devices [Tyson Bio AC500 Blood Glucose Monitoring System ]

• 14719869703498: AC500
• 14719869703481: AC500
• 14719869703108: AC500
• 14719869703054: AC500