Tenovi
- Primary DI
- G004TCCST010
- Brand
- Tenovi
- Company
- Tenovi Co.
- Model
- TC-CST-01
- Device description
- Tenovi Cellular Glucometer Test Strips
- Published
- 2024-01-26
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- true
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| NBW | System, Test, Blood Glucose, Over The Counter |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| NBW | System, Test, Blood Glucose, Over The Counter | Clinical Chemistry | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| G004TCCST010 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Glucose monitoring system IVD, home-use | A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus. |
Regulatory Flags
- DUNS number
- 127061577
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00850080988114 | AUVON | UAN HEALTHCARE LIMITED | NBW | 2026-03-02 |
| 00860003164518 | Rosie | Southern Life Systems, Inc. | NBW | 2026-03-02 |
| 00860003164570 | Rosie | Southern Life Systems, Inc. | NBW | 2026-03-02 |
| 00810079240531 | Teladoc Health, Inc. | Teladoc Health, Inc. | NBW | 2026-02-17 |
| 00810079240548 | Teladoc Health, Inc. | Teladoc Health, Inc. | NBW | 2026-02-17 |
| 00810079240555 | Teladoc Health, Inc. | Teladoc Health, Inc. | NBW | 2026-02-17 |
| 10041260007351 | TRUE METRIX AIR | TRIVIDIA HEALTH, INC. | NBW | 2026-02-09 |
| 00850080988091 | AUVON | UAN HEALTHCARE LIMITED | NBW | 2026-02-06 |
| 00850001462136 | GOJJI Plus TestNGo MULTIFUNCTION (GLUC-KETONE) METER | GOJJI, INC. | NBW | 2026-02-01 |
| 00860015091659 | KetoBM | KETOBM USA LLC | NBW | 2026-01-19 |
| 00860015091666 | KetoBM | KETOBM USA LLC | NBW | 2026-01-19 |
| 00850068074174 | Tenovi | Tenovi Co. | NBW | 2026-01-02 |
| 00850068074266 | Tenovi | Tenovi Co. | NBW | 2026-01-02 |
| 07506555400003 | Glucheck Self-Monitoring Blood Glucose System | EPS BIO TECHNOLOGY CORP. | NBW | 2026-01-02 |
| 27506555400014 | Glucheck Blood Glucose Test Strip | EPS BIO TECHNOLOGY CORP. | NBW | 2026-01-02 |
| 00850063675956 | metene S BLOOD GLUCOSE MONITORING SYSTEM | METENE LIMITED | NBW | 2025-12-24 |
| 10850044118776 | iHealth | IHEALTH LAB INC. | NBW | 2025-12-19 |
| 10850044118806 | iHealth | IHEALTH LAB INC. | NBW | 2025-12-19 |
| 10856362005156 | iHealth | IHEALTH LAB INC. | NBW | 2025-12-19 |
| 00199284201354 | SureMediks B-ketone & blood glucose monitoring system | Rasimo Systems LLC | NBW | 2025-12-05 |
| 00816042016066 | FORA | FORA CARE INC. | NBW | 2025-12-05 |
| 00883489002662 | iGlucose Touch Blood Glucose Meter | BIONIME CORPORATION | NBW | 2025-12-04 |
| 00883489002686 | iGlucose Touch Blood Glucose Test Strip | BIONIME CORPORATION | NBW | 2025-12-04 |
| 00883489002709 | iGlucose Touch Control Solution | BIONIME CORPORATION | NBW | 2025-12-04 |
| 10385540109732 | CareSens S Fit BT | AgaMatrix, Inc. | NBW | 2025-11-30 |
| 00050428284391 | CVS Health | WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | NBW | 2025-11-30 |
| 00050428284483 | CVS Health | WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | NBW | 2025-11-30 |
| 10075450843573 | TRUE METRIX GO | TRIVIDIA HEALTH, INC. | NBW | 2025-11-26 |
| 00850068074457 | Tenovi | Tenovi Co. | NBW | 2025-11-20 |
| 20385540109722 | CareSens S Fit | AGAMATRIX, INC. | NBW | 2025-08-04 |