Tyson Bio HS100 Control Solution (Level 3)

GUDID 14719869705874

TYSON BIORESEARCH INC.

Glucose IVD, control

• Primary Device ID: 14719869705874
• NIH Device Record Key: 84ff3e83-8c88-43a0-a59b-ec0cb9180f60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tyson Bio HS100 Control Solution (Level 3)
• Version Model Number: HS100
• 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	04719869705877 [Primary]
GS1	14719869705874 [Package]; Contains: 04719869705877; Package: [20 Units]; In Commercial Distribution
GS1	24719869705871 [Package]; Contains: 04719869705877; Package: [1000 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: 2024-12-12
• Device Publish Date: 2024-12-04

Devices Manufactured by TYSON BIORESEARCH INC.

• 14719869705850 - Tyson Bio HS100 Control Solution (Level 1): 2024-12-12
• 14719869705867 - Tyson Bio HS100 Control Solution (Level 2): 2024-12-12
• 14719869705874 - Tyson Bio HS100 Control Solution (Level 3): 2024-12-12
• 14719869705874 - Tyson Bio HS100 Control Solution (Level 3): 2024-12-12
• 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