TRUE METRIX PRO RE4068P-01

GUDID 00607415261097

MooreBrand Professional Monitoring Blood Glucose Meter TRUE METRIX PRO

TRIVIDIA HEALTH, INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 00607415261097
• NIH Device Record Key: 4c1117aa-fdb7-4565-8a79-9dbf503caf36
• Commercial Distribution Discontinuation: 2018-05-11
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: TRUE METRIX PRO
• Version Model Number: Professional Monitoring Blood Glucose Meter TRUE M
• Catalog Number: RE4068P-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: 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00607415261097 [Primary]
GS1	10607415261094 [Package]; Package: Case [6 Units]; Discontinued: 2018-05-11; 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: 3
• Public Version Date: 2018-06-12
• Device Publish Date: 2016-09-20

On-Brand Devices [TRUE METRIX PRO]

• 00607415261097: MooreBrand Professional Monitoring Blood Glucose Meter TRUE METRIX PRO
• 10021292006102: TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE METER
• 10021292014916: Henry Schein TRUE METRIX professional monitoring blood glucose meter
• 10021292006096: TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE METER FOR MULTIPLE PATIENT USE