My-TECH TF4H01-00

GUDID 00021292012991

My-TECH Ring Self Monitoring Blood Glucose Meter

TRIVIDIA HEALTH, INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 00021292012991
• NIH Device Record Key: e259d8ce-41db-4aa5-b669-ff50fd147c99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: My-TECH
• Version Model Number: My-TECH Ring Self Monitoring Blood Glucose Meter
• Catalog Number: TF4H01-00
• 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: 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
• 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
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00021292012991 [Direct Marking]
GS1	00021292013097 [Primary]
GS1	10021292013094 [Package]; Contains: 00021292013097; Package: CASE [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143548

FDA Product Code

• LFR: Glucose Dehydrogenase, Glucose

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-10-16
• Device Publish Date: 2019-08-08

On-Brand Devices [My-TECH]

• 10021292013117: My-TECH Self Monitoring Blood Glucose Test Strips
• 00021292012991: My-TECH Ring Self Monitoring Blood Glucose Meter