Tyson Bio HT100 Control Solution Level 2

GUDID 04719869701947

TYSON BIORESEARCH INC.

Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control

• Primary Device ID: 04719869701947
• NIH Device Record Key: 8a9f6150-1571-4607-890c-3eca58fd1c38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tyson Bio HT100 Control Solution Level 2
• 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	04719869701947 [Primary]
GS1	14719869701944 [Package]; Package: [50 Units]; In Commercial Distribution
GS1	24719869701941 [Package]; Package: [1000 Units]; In Commercial Distribution
GS1	34719869701948 [Package]; 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: 2018-08-17
• Device Publish Date: 2018-07-17

Devices Manufactured by TYSON BIORESEARCH INC.

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• 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
• 14719869704174 - Tyson Bio HT100-B Control Solution Level 2: 2023-02-27
• 14719869704181 - Tyson Bio HT100-B Control Solution Level 1: 2023-02-27