Tyson Bio HT100-B Control Solution Level 3

GUDID 14719869704167

TYSON BIORESEARCH INC.

Glucose IVD, control

• Primary Device ID: 14719869704167
• NIH Device Record Key: acbe0840-76d1-4d57-9b54-9d1ec98626fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tyson Bio HT100-B Control Solution Level 3
• Version Model Number: HT100-B
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719869704160 [Primary]
GS1	14719869704167 [Package]; Contains: 04719869704160; Package: [50 Units]; In Commercial Distribution
GS1	24719869704164 [Package]; Contains: 04719869704160; Package: [1000 Units]; In Commercial Distribution
GS1	34719869704161 [Package]; Contains: 04719869704160; Package: [20 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: 2023-02-27
• Device Publish Date: 2023-02-17

Devices Manufactured by TYSON BIORESEARCH INC.

• 14719869705881 - Tyson Bio HS100 Blood Glucose Test Strips: 2024-11-19
• 04719869705891 - Tyson Bio HS100 Blood Glucose Test Strips: 2024-11-19
• 14719869702033 - Tyson Bio HS100 Blood Glucose Monitoring System: 2023-09-04
• 14719869702095 - Tyson Bio HS100-B Blood Glucose Monitoring System: 2023-09-04
• 04719869705396 - Tyson Bio HT100 Blood Glucose Meter: 2023-08-15
• 14719869703221 - Tyson Bio HT100 Blood Glucose Monitoring System: 2023-02-27
• 14719869703306 - Tyson Bio HT100-B Blood Glucose Monitoring System: 2023-02-27
• 14719869704167 - Tyson Bio HT100-B Control Solution Level 3: 2023-02-27
• 14719869704167 - Tyson Bio HT100-B Control Solution Level 3: 2023-02-27