TRUE METRIX RE4H01-51
GUDID 10021292014947
TRUE METRIX Self Monitoring Blood Glucose Meter
TRIVIDIA HEALTH, INC.
Glucose monitoring system IVD, home-use| Primary Device ID | 10021292014947 |
| NIH Device Record Key | 605e9ef4-852b-42c7-9cd5-a6772d435a93 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRUE METRIX |
| Version Model Number | TRUE METRIX Self Monitoring Blood Glucose Meter |
| Catalog Number | RE4H01-51 |
| 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 |
| customercare@trividiahealth.com | |
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com | |
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com | |
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com | |
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com | |
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com | |
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com | |
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com | |
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com | |
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com | |
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com | |
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com | |
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com | |
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00021292007690 [Direct Marking] |
| GS1 | 00021292014940 [Primary] |
| GS1 | 10021292014947 [Package] Contains: 00021292014940 Package: case [12 Units] 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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-09-07 |
| Device Publish Date | 2022-08-30 |
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| 10713733069813 | meijer TRUE METRIX Self Monitoring Blood Glucose Meter |
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| 10052569140113 | TRUE METRIX SELF MONITORING BLOOD GLUCOSE TEST STRIPS - 30 Test Strips |
| 00021292007690 | Leader TRUE METRIX PRE-PACK 4x24 |
| 10021292008908 | Shopko TRUE METRIX Self Monitoring Blood Glucose Meter |
| 00021292007829 | TRUE METRIX SELF MONITORING BLOOD GLUCOSE TEST STRIPS - 25 Test Strips |
| 50096295139551 | Leader TRUE METRIX PRE-PACK 4x24 |
| 10021292008632 | GOOD NEIGHBOR PHARMACY TRUE METRIX PRE-PACK |
| 10021292007215 | Health Mart PHARMACY TRUE METRIX PRE-PACK |
| 10021292007000 | TRUE METRIX PRE-PACK - USE ONLY FOR MEDICARE AND MEDICAID |
| 00021292006259 | TRUE METRIX Control Solution Level 3 |
| 00021292006242 | TRUE METRIX Control Solution Level 2 |
| 00021292006235 | TRUE METRIX Control Solution Level 1 |
| 10681131240168 | Relion TRUE METRIX Self Monitoring Blood Glucose Test Strips - 50ct Test Strips |
| 10021292008892 | TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER |
| 10021292014794 | TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM Starter Kit - FOR HUMANA |
| 10041260016025 | Kroger TRUE METRIX Self Monitoring Blood Glucose Meter Kit |
| 10021292014947 | TRUE METRIX Self Monitoring Blood Glucose Meter |
| 10021292014909 | Henry Schein TRUE METRIX self monitoring blood glucose meter |
| 10021292007192 | sunmark TRUE METRIX PRE-PACK |
| 10010939722444 | sunmark TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER - FREE METER ONLY |
| 10010939719444 | sunmark TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER |
Trademark Results [TRUE METRIX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRUE METRIX 86278575 4765774 Live/Registered |
TRIVIDIA HEALTH, INC. 2014-05-12 |
 TRUE METRIX 85429718 4637504 Live/Registered |
TRIVIDIA HEALTH, INC. 2011-09-22 |
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