Tyson Bio HS100 Blood Glucose Test Strips

GUDID 04719869705891

TYSON BIORESEARCH INC.

Glucose IVD, kit, electrometry

• Primary Device ID: 04719869705891
• NIH Device Record Key: 3f6eec65-e082-458b-b0ac-54f102838a2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tyson Bio HS100 Blood Glucose Test Strips
• 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	04719869705891 [Primary]
GS1	14719869705898 [Package]; Package: [250 Units]; In Commercial Distribution
GS1	24719869705895 [Package]; 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: 2024-11-19
• Device Publish Date: 2024-11-11

On-Brand Devices [Tyson Bio HS100 Blood Glucose Test Strips]

• 04719869705891: HS100
• 14719869705881: HS100