FDA device listing
Sugarmate Platform,Tandem Source,t:connect Web Application
FDA device listing 1895851510 · Tandem Diabetes Care, Inc.
Key facts
| Proprietary names | Sugarmate Platform,Tandem Source,t:connect Web Application |
|---|---|
| Owner/operator | Tandem Diabetes Care, Inc. |
| Owner/operator number | 10039506 |
| Product codes | PHV |
| Device names | PHV - Continuous Glucose Monitor Retrospective Data Analysis Software |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.2120 |
| Review panels | Clinical Chemistry |
| Registered establishments | TANDEM DIABETES CARE, INC. |
| Establishment registrations | 3007981285 |
| FEI numbers | 3007981285 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database