TRUENESS AIR

GUDID 10021292015043

TRUENESS AIR Blood Glucose Meter

TRIVIDIA HEALTH, INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 10021292015043
• NIH Device Record Key: 91fa853d-8e30-4027-8483-3a57175f4061
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRUENESS AIR
• Version Model Number: TRUENESS AIR Blood Glucose Meter
• 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: false
• 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
• 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

• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *relative humidity levels less than 95%RH (non-condensing)
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *relative humidity levels less than 95%RH (non-condensing)
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *relative humidity levels less than 95%RH (non-condensing)
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *relative humidity levels less than 95%RH (non-condensing)
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *relative humidity levels less than 95%RH (non-condensing)
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *relative humidity levels less than 95%RH (non-condensing)
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *relative humidity levels less than 95%RH (non-condensing)
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *relative humidity levels less than 95%RH (non-condensing)
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *relative humidity levels less than 95%RH (non-condensing)
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *relative humidity levels less than 95%RH (non-condensing)
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *relative humidity levels less than 95%RH (non-condensing)
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *relative humidity levels less than 95%RH (non-condensing)
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *relative humidity levels less than 95%RH (non-condensing)
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *relative humidity levels less than 95%RH (non-condensing)
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *relative humidity levels less than 95%RH (non-condensing)
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *relative humidity levels less than 95%RH (non-condensing)
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *relative humidity levels less than 95%RH (non-condensing)

Device Identifiers

Device Issuing Agency	Device ID
GS1	00021292015046 [Primary]
GS1	00021292015121 [Direct Marking]
GS1	10021292015043 [Package]; Contains: 00021292015046; Package: Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231476

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: 2024-04-11
• Device Publish Date: 2024-04-03

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