TysonBio AC500 Control Solution (Level 3)

GUDID 14719869703160

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

• Primary Device ID: 14719869703160
• NIH Device Record Key: 7abef2e6-8254-4130-b2d0-1d1a8a3ef424
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TysonBio AC500 Control Solution (Level 3)
• 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: 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	04719869703163 [Primary]
GS1	14719869703160 [Package]; Contains: 04719869703163; Package: [100 Units]; In Commercial Distribution
GS1	24719869703167 [Package]; Contains: 04719869703163; Package: [1000 Units]; In Commercial Distribution
GS1	34719869703164 [Package]; Contains: 04719869703163; Package: [20 Units]; Discontinued: 2022-04-07; Not 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

Devices Manufactured by TYSON BIORESEARCH INC.

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