TRUE METRIX GO RF4209-01

GUDID 00021292007706

TopCare TRUE METRIX GO Self Monitoring Blood Glucose Meter

TRIVIDIA HEALTH, INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 00021292007706
• NIH Device Record Key: c1d7c326-838f-4090-aa49-bcd7fbd5c8ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRUE METRIX GO
• Version Model Number: TRUE METRIX GO Self Monitoring Blood Glucose Meter
• Catalog Number: RF4209-01
• 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: 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
• 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
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00021292007706 [Direct Marking]
GS1	00036800234567 [Primary]
GS1	10036800234564 [Package]; Contains: 00036800234567; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-03
• Device Publish Date: 2019-04-25

On-Brand Devices [TRUE METRIX GO]

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