TRUE METRIX AIR REA4081-01

GUDID 10021292015012

Humana/CenterWell TRUE METRIX AIR Self Monitoring Blood Glucose Meter Kit

TRIVIDIA HEALTH, INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 10021292015012
• NIH Device Record Key: f2ffe93d-e0a7-46c5-80b6-465f9d36b344
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRUE METRIX AIR
• Version Model Number: TRUE METRIX AIR Self Monitoring Blood Glucose Me
• Catalog Number: REA4081-01
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• 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: 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

• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00021292007720 [Direct Marking]
GS1	00021292015015 [Primary]
GS1	10021292015012 [Package]; Contains: 00021292015015; Package: case [12 Units]; In Commercial Distribution

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: 2023-09-14
• Device Publish Date: 2023-09-06

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