TRUENESS
GUDID 10021292015036
TRUENESS Blood Glucose Meter
TRIVIDIA HEALTH, INC.
Glucose monitoring system IVD, home-use| Primary Device ID | 10021292015036 |
| NIH Device Record Key | 655c802b-04c3-4b80-bf13-732bcde2dc29 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRUENESS |
| Version Model Number | TRUENESS Blood Glucose Meter |
| 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 | false |
| 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 | false |
| 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 | |
| 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
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *at relative humidity levels less than 95%RH (non-condensing) |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *at relative humidity levels less than 95%RH (non-condensing) |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *at relative humidity levels less than 95%RH (non-condensing) |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *at relative humidity levels less than 95%RH (non-condensing) |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *at relative humidity levels less than 95%RH (non-condensing) |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *at relative humidity levels less than 95%RH (non-condensing) |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *at relative humidity levels less than 95%RH (non-condensing) |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *at relative humidity levels less than 95%RH (non-condensing) |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *at relative humidity levels less than 95%RH (non-condensing) |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *at relative humidity levels less than 95%RH (non-condensing) |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *at relative humidity levels less than 95%RH (non-condensing) |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *at relative humidity levels less than 95%RH (non-condensing) |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *at relative humidity levels less than 95%RH (non-condensing) |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *at relative humidity levels less than 95%RH (non-condensing) |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *at relative humidity levels less than 95%RH (non-condensing) |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *at relative humidity levels less than 95%RH (non-condensing) |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *at relative humidity levels less than 95%RH (non-condensing) |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00021292015039 [Primary] |
| GS1 | 00021292015114 [Direct Marking] |
| GS1 | 10021292015036 [Package] Contains: 00021292015039 Package: Case [12 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K231476
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 | 2024-04-11 |
| Device Publish Date | 2024-04-03 |
On-Brand Devices [TRUENESS]
| 00021292015077 | TRUENESS Control Solution Level 2 |
| 00021292015060 | TRUENESS Control Solution Level 1 |
| 00021292015053 | TRUENESS Blood Glucose Test Strips |
| 10021292015036 | TRUENESS Blood Glucose Meter |
Trademark Results [TRUENESS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRUENESS 97523565 not registered Live/Pending |
Trividia Health, Inc. 2022-07-28 |
 TRUENESS 97496696 not registered Live/Pending |
Trividia Health, Inc. 2022-07-11 |
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