TRUE FOCUS UE4001-00

GUDID 10311917188062

Walgreens TRUE FOCUS Self Monitoring Blood Glucose Meter box

TRIVIDIA HEALTH, INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 10311917188062
• NIH Device Record Key: 4de9114c-3c1f-460b-9bb4-56019aa89b43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRUE FOCUS
• Version Model Number: TRUE FOCUS Self Monitoring Blood Glucose Meter
• Catalog Number: UE4001-00
• Company DUNS: 151810868
• Company Name: TRIVIDIA HEALTH, 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(800) 803-6025
• Email: customercare@trividiahealth.com
• Phone: +1(800) 803-6025
• Email: customercare@trividiahealth.com
• Phone: +1(800) 803-6025
• Email: customercare@trividiahealth.com
• Phone: +1(800) 803-6025
• Email: customercare@trividiahealth.com
• Phone: +1(800) 803-6025
• Email: customercare@trividiahealth.com
• Phone: +1(800) 803-6025
• Email: customercare@trividiahealth.com
• Phone: +1(800) 803-6025
• Email: customercare@trividiahealth.com
• Phone: +1(800) 803-6025
• Email: customercare@trividiahealth.com
• Phone: +1(800) 803-6025
• Email: customercare@trividiahealth.com
• Phone: +1(800) 803-6025
• Email: customercare@trividiahealth.com
• Phone: +1(800) 803-6025
• Email: customercare@trividiahealth.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00021292007744 [Direct Marking]
GS1	00311917188065 [Primary]
GS1	10311917188062 [Package]; Contains: 00311917188065; Package: CASE [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131013

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-12
• Device Publish Date: 2017-06-21

On-Brand Devices [TRUE FOCUS]

• 10311917188062: Walgreens TRUE FOCUS Self Monitoring Blood Glucose Meter box
• 00021292005726: TRUE FOCUS Control Solution Level 3
• 00021292005719: TRUE FOCUS Control Solution Level 2
• 00021292005702: TRUE FOCUS Control Solution Level 1