Tyson Bio HS100 Blood Glucose Test Strips

GUDID 14719869705881

TYSON BIORESEARCH INC.

Glucose IVD, kit, electrometry

• Primary Device ID: 14719869705881
• NIH Device Record Key: 94a6d4ec-a531-4070-9797-34f86db2e5ca
• 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	04719869705884 [Primary]
GS1	14719869705881 [Package]; Contains: 04719869705884; Package: [250 Units]; In Commercial Distribution
GS1	24719869705888 [Package]; Contains: 04719869705884; 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