UDI device identifier
TRUEbalance TRUEbalance BLOOD GLUCOSE MONITORING SYSTEM
UDI device identifier 00021292003135 · TRIVIDIA HEALTH, INC.
Key facts
| Primary DI | 00021292003135 |
|---|---|
| Brand name | TRUEbalance |
| Version or model | TRUEbalance BLOOD GLUCOSE MONITORING SYSTEM |
| Catalog number | H4H01-81 |
| Company | TRIVIDIA HEALTH, INC. |
| DUNS number | 151810868 |
| Product code | NBW |
| GMDN term | Glucose monitoring system IVD, home-use |
| Premarket submission | K090495 |
| Device class | Class II |
| Single use | No |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Sep 20, 2016 |
| Version date | Nov 1, 2021 |
| Description | TRUEbalance BLOOD GLUCOSE MONITORING SYSTEM |
At a glance
- 10–99 MAUDE reports citing this UDI
- Yes Linked premarket submission
- No EUDAMED counterpart found
- 1,000+ GUDID devices with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About UDI device identifiers (GUDID)
The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.
Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date: