TRUEtrack A4007-81

GUDID 10050428264703

CVS Health TRUEtrack Blood Glucose Monitoring System - Meter Kit

TRIVIDIA HEALTH, INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 10050428264703
• NIH Device Record Key: 713daa34-8e6a-481f-b0d2-c29a5b59a068
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRUEtrack
• Version Model Number: TRUEtrack Blood Glucose Monitoring System
• Catalog Number: A4007-81
• Company DUNS: 151810868
• Company Name: TRIVIDIA HEALTH, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does n
• 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.co
• 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 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00050428264706 [Primary]
GS1	10050428264703 [Package]; Contains: 00050428264706; Package: CASE [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032657

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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: 2018-03-29
• Device Publish Date: 2016-12-22

On-Brand Devices [TRUEtrack]

• 00096295129489: LEADER TRUEtrack Blood Glucose Meter – FREE METER ONLY – CANNOT SUBMIT FOR REIMBURSEMENT
• 50096295111861: LEADER TRUEtrack Blood Glucose Monitoring System
• 10093351115520: DISCOUNT drug mart FOOD FAIR TRUEtrack BLOOD GLUCOSE METER
• 10087701866804: GOOD NEIGHBOR PHARMACY TRUEtrack BLOOD GLUCOSE MONITORING SYSTEM
• 10087701405577: GOOD NEIGHBOR PHARMACY TRUEtrack BLOOD GLUCOSE METER - FREE METER ONLY
• 00052569132463: Health Mart PHARMACY TRUEtrack blood glucose monitoring system
• 10050428318017: CVS Health TRUEtrack Blood Glucose Monitoring System
• 10050428264703: CVS Health TRUEtrack Blood Glucose Monitoring System - Meter Kit
• 00847717034009: Vida Mia mi salud TRUEtrack Blood Glucose Meter Medidor de Glucosa en la Sangre
• 50021292008609: LEADER TRUEtrack PRE-PACK
• 00030034055479: GIANT EAGLE TRUEtrack BLOOD GLUCOSE MONITORING SYSTEM
• 00021292008642: TRUEtrack 50 Blood Glucose Test Strips
• 00021292001797: TRUEtrack BLOOD GLUCOSE METER - FREE METER ONLY
• 10041415028781: Publix truetrack ACCURATE BLOOD GLUCOSE METER
• 10041220842435: H-E-B in Control TRUEtrack Blood Glucose Monitoring System
• 00021292008888: TRUEtrack 25 Blood Glucose Test Strips
• 10021292004573: Health Wise PHARMACY TRUEtrack BLOOD GLUCOSE MONITORING SYSTEM
• 00021292001971: TRUEtrack BLOOD GLUCOSE MONITORING SYSTEM NOT FOR RETAIL SALE
• 00021292001018: TRUEtrack BLOOD GLUCOSE MONITORING SYSTEM
• 10011822577547: RITE AID PHARMACY TRUEtrack blood glucose monitor
• 10010939755336: sunmark TRUEtrack BLOOD GLUCOSE MONITORING SYSTEM
• 10052569138479: Health Mart PHARMACY TRUEtrack PRE-PACK
• 10021292008625: Preferred Plus Pharmacy TRUEtrack PRE-PACK
• 10021292008618: GOOD NEIGHBOR PHARMACY TRUEtrack PRE-PACK
• 10021292006874: HealthWise PHARMACY TRUEtrack PRE-PACK
• 10021292006867: Sunmark TRUEtrack PRE-PACK
• 10021292006843: TRUEtrack PRE-PACK
• 10021292009288: HealthWise Pharmacy TRUEtrack Blood Glucose Meter - Free Meter Only
• 00021292008932: TRUEtrack 10 Blood Glucose Test Strips
• 10021292003217: Preferred Plus Pharmacy TRUEtrack BLOOD GLUCOSE METER - FREE METER ONLY
• 10021292001268: Preferred Plus Pharmacy TRUEtrack BLOOD GLUCOSE METER