Tyson Bio HT100 Blood Glucose Monitoring System

GUDID 14719869701791

TYSON BIORESEARCH INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 14719869701791
• NIH Device Record Key: 478d8ab6-655d-4047-b34e-47c116cdf865
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tyson Bio HT100 Blood Glucose Monitoring System
• Version Model Number: HT100
• 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: 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	04719869701794 [Primary]
GS1	14719869701791 [Package]; Contains: 04719869701794; Package: [80 Units]; In Commercial Distribution
GS1	24719869701798 [Package]; Contains: 04719869701794; Package: [72 Units]; In Commercial Distribution
GS1	34719869701825 [Package]; Contains: 04719869701794; Package: [250 Units]; In Commercial Distribution
GS1	44719869701822 [Package]; Contains: 04719869701794; Package: [500 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170079

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: 2018-08-17
• Device Publish Date: 2018-07-17

On-Brand Devices [Tyson Bio HT100 Blood Glucose Monitoring System ]

• 14719869701791: HT100
• 14719869703016: HT100
• 14719869703221: HT100