Primary Device ID | 00021292015077 |
NIH Device Record Key | 9e4e293b-a72f-45af-b483-07f3c12efb42 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | TRUENESS |
Version Model Number | TRUENESS Control Solution |
Company DUNS | 151810868 |
Company Name | TRIVIDIA HEALTH, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | true |
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 |
Storage Environment Temperature | Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
Storage Environment Temperature | Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
Storage Environment Temperature | Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
Storage Environment Temperature | Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
Storage Environment Temperature | Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
Storage Environment Temperature | Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
Storage Environment Temperature | Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
Storage Environment Temperature | Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
Storage Environment Temperature | Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
Storage Environment Temperature | Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
Storage Environment Temperature | Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
Storage Environment Temperature | Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
Storage Environment Temperature | Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
Storage Environment Temperature | Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
Storage Environment Temperature | Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
Storage Environment Temperature | Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
Storage Environment Temperature | Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00021292015077 [Package] Contains: 00021292015107 Package: Box [1 Units] In Commercial Distribution |
GS1 | 00021292015107 [Primary] |
GS1 | 10021292015074 [Package] Package: Case [400 Units] In Commercial Distribution |
JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-04-11 |
Device Publish Date | 2024-04-03 |
00021292015077 | TRUENESS Control Solution Level 2 |
00021292015060 | TRUENESS Control Solution Level 1 |
00021292015053 | TRUENESS Blood Glucose Test Strips |
10021292015036 | TRUENESS Blood Glucose Meter |
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 |