My-TECH
GUDID 10021292013117
My-TECH Self Monitoring Blood Glucose Test Strips
TRIVIDIA HEALTH, INC.
Glucose monitoring system IVD, home-use| Primary Device ID | 10021292013117 |
| NIH Device Record Key | 2c694492-19be-40ef-958d-c256e513d3ad |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | My-TECH |
| Version Model Number | My-TECH Self Monitoring Blood Glucose Test Strips |
| Company DUNS | 151810868 |
| Company Name | TRIVIDIA HEALTH, INC. |
| Device Count | 50 |
| 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
Operating and Storage Conditions
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00021292013103 [Package] Contains: 00021292013127 Package: Box [1 Units] In Commercial Distribution |
| GS1 | 00021292013110 [Package] Contains: 00021292013127 Package: Box [2 Units] In Commercial Distribution |
| GS1 | 00021292013127 [Primary] |
| GS1 | 00021292013943 [Unit of Use] |
| GS1 | 10021292013100 [Package] Contains: 00021292013103 Package: Case [24 Units] In Commercial Distribution |
| GS1 | 10021292013117 [Package] Contains: 00021292013110 Package: Case [12 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K143548
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 | 2 |
| Public Version Date | 2023-10-16 |
| Device Publish Date | 2019-08-08 |
On-Brand Devices [My-TECH]
| 10021292013117 | My-TECH Self Monitoring Blood Glucose Test Strips |
| 00021292012991 | My-TECH Ring Self Monitoring Blood Glucose Meter |
Trademark Results [My-TECH]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MY-TECH 88248619 not registered Live/Pending |
Trividia Health, Inc. 2019-01-03 |
 MY-TECH 88217873 not registered Live/Pending |
Trividia Health, Inc. 2018-12-05 |
 MY-TECH 79373824 not registered Live/Pending |
HY-TECH DRILLING LTD. 2023-05-17 |
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