TRUE METRIX GO RF4H01-01BK

GUDID 10021292006119

TRUE METRIX GO Self Monitoring Blood Glucose Meter

TRIVIDIA HEALTH, INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 10021292006119
• NIH Device Record Key: e1509d0b-fee9-4952-9a86-4336f3cfd662
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRUE METRIX GO
• Version Model Number: TRUE METRIX GO Self Monitoring Blood Glucose Meter
• Catalog Number: RF4H01-01BK
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00021292006112 [Primary]
GS1	00021292007706 [Direct Marking]
GS1	10021292006119 [Package]; Contains: 00021292006112; 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: 4
• Public Version Date: 2023-10-16
• Device Publish Date: 2017-04-13

On-Brand Devices [TRUE METRIX GO]

• 10311917178698: Walgreens TRUE METRIX GO Self Monitoring Blood Glucose Meter
• 10708820721095: Meijer TRUE METRIX GO Self Monitoring Blood Glucose Meter Kit Box
• 10050428560409: CVS Health TRUE METRIX GO Self-Monitoring Blood Glucose Meter
• 00021292007706: TopCare TRUE METRIX GO Self Monitoring Blood Glucose Meter
• 10021292009332: Fred's TRUE METRIX GO Self Monitoring Blood Glucose Meter Kit box
• 10021292009790: TRUE METRIX GO Self Monitoring Blood Glucose Meter - Not For Retail Sale - Meter Only
• 10011822002780: Rite Aid TRUE METRIX GO Self Monitoring Blood Glucose Meter
• 10041220136138: HEB TRUE METRIX GO Self Monitoring Blood Glucose Meter Kit
• 10021292006119: TRUE METRIX GO Self Monitoring Blood Glucose Meter