TRUE METRIX RE4098-01

GUDID 10021292008908

Shopko TRUE METRIX Self Monitoring Blood Glucose Meter

TRIVIDIA HEALTH, INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 10021292008908
• NIH Device Record Key: 0be12f38-b511-4841-bc7a-142f2e92f000
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRUE METRIX
• Version Model Number: TRUE METRIX Self Monitoring Blood Glucose Meter
• Catalog Number: RE4098-01
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00021292007690 [Direct Marking]
GS1	00021292008901 [Primary]
GS1	10021292008908 [Package]; Contains: 00021292008901; Package: Case [12 Units]; Discontinued: 2019-04-29; Not 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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-17
• Device Publish Date: 2016-09-30

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