TRUE FOCUS

GUDID 00021292005719

TRUE FOCUS Control Solution Level 2

TRIVIDIA HEALTH, INC.

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• Primary Device ID: 00021292005719
• NIH Device Record Key: 1ca3018b-4eb7-422c-b3f5-6b1a89b67afa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRUE FOCUS
• Version Model Number: TRUE FOCUS Control Solution Level 2
• 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• 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
• Phone: +1(800)803-6025
• Email: customercare@trividiahealth.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE

Device Identifiers

Device Issuing Agency	Device ID
GS1	00021292005719 [Package]; Contains: 00021292008437; Package: BOX [1 Units]; In Commercial Distribution
GS1	00021292008437 [Primary]
GS1	10021292005716 [Package]; Package: CASE [24 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-08
• Device Publish Date: 2021-02-26

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