FDA device listing
t:slim X2 with Basal-IQ technology
FDA device listing 1388382873 · Tandem Diabetes Care, Inc.
Key facts
| Proprietary names | t:slim X2 with Basal-IQ technology |
|---|---|
| Owner/operator | Tandem Diabetes Care, Inc. |
| Owner/operator number | 10039506 |
| Premarket submissions | K201214 |
| Product codes | QFG |
| Device names | QFG - Alternate Controller Enabled Insulin Infusion Pump |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5730 |
| Review panels | Clinical Chemistry |
| Registered establishments | Tandem Diabetes Care Europe B.V., Tandem Diabetes Care, INC., TANDEM DIABETES CARE, INC. |
| Establishment registrations | 3007981285, 3013756811, 3016540876, 3026266833, 3032746481 |
| FEI numbers | 3007981285, 3013756811, 3016540876, 3026266833, 3032746481 |
| Establishment operations | Complaint File Establishment, Specification Developer, Foreign Exporter, Manufacturer, Remanufacturer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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