UDI device identifier
Tandem Mobi 1012719
UDI device identifier 00389152271910 · Tandem Diabetes Care, Inc.
Key facts
| Primary DI | 00389152271910 |
|---|---|
| Brand name | Tandem Mobi |
| Version or model | 1012719 |
| Company | Tandem Diabetes Care, Inc. |
| DUNS number | 827900809 |
| Product code | QFG |
| GMDN term | Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm |
| Premarket submission | K223213 |
| Device class | Class II |
| Single use | No |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Oct 30, 2023 |
| Version date | Nov 7, 2023 |
| Description | Tandem Mobi Pump with Control-IQ, Replacement |
At a glance
- 1–9 MAUDE reports citing this UDI
- Yes Linked premarket submission
- No EUDAMED counterpart found
- 100–999 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: