TRUE METRIX

GUDID 00021292007829

TRUE METRIX SELF MONITORING BLOOD GLUCOSE TEST STRIPS - 25 Test Strips

TRIVIDIA HEALTH, INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 00021292007829
• NIH Device Record Key: c556653e-e3d2-4083-ae03-9b0a1c6839d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRUE METRIX
• Version Model Number: TRUE METRIX SELF MONITORING BLOOD GLUCOSE TEST STR
• Company DUNS: 151810868
• Company Name: TRIVIDIA HEALTH, INC.
• Device Count: 25
• 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: true
• Lot Batch: true
• Serial Number: false
• 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	00021292006174 [Package]; Package: Box [1 Units]; In Commercial Distribution
GS1	00021292007409 [Package]; Package: Box [1 Units]; Discontinued: 2019-11-18; Not in Commercial Distribution
GS1	00021292007799 [Unit of Use]
GS1	00021292007829 [Primary]
GS1	00041220001293 [Package]; Package: Box [1 Units]; In Commercial Distribution
GS1	00041415069787 [Package]; Package: Box [1 Units]; In Commercial Distribution
GS1	00050428558348 [Package]; Package: Box [1 Units]; In Commercial Distribution
GS1	00087701426728 [Package]; Package: Box [1 Units]; Discontinued: 2017-10-12; Not in Commercial Distribution
GS1	00311917173887 [Package]; Package: Box [1 Units]; In Commercial Distribution
GS1	00725439988940 [Package]; Package: Box [1 Units]; Discontinued: 2020-02-25; Not in Commercial Distribution
GS1	10021292006171 [Package]; Package: Case [24 Units]; In Commercial Distribution
GS1	10021292007406 [Package]; Package: Case [24 Units]; Discontinued: 2019-11-18; Not in Commercial Distribution
GS1	10041220001290 [Package]; Package: Case [24 Units]; In Commercial Distribution
GS1	10041415069784 [Package]; Contains: 00041415069787; Package: Case [24 Units]; In Commercial Distribution
GS1	10050428558345 [Package]; Contains: 00050428558348; Package: Case [24 Units]; In Commercial Distribution
GS1	10087701426725 [Package]; Package: Case [24 Units]; Discontinued: 2017-10-12; Not in Commercial Distribution
GS1	10311917173884 [Package]; Package: Case [24 Units]; In Commercial Distribution
GS1	10725439988947 [Package]; Contains: 00725439988940; Package: Case [24 Units]; Discontinued: 2020-02-25; Not in Commercial Distribution

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: 2020-03-10
• Device Publish Date: 2016-09-20

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