FDA device listing
Dexcom G7 15 Day Continuous Glucose Monitoring System,Dexcom G7 Continuous Glucose Monitoring System
FDA device listing 1545106467 · DEXCOM, INC.
Key facts
| Proprietary names | Dexcom G7 15 Day Continuous Glucose Monitoring System,Dexcom G7 Continuous Glucose Monitoring System |
|---|---|
| Owner/operator | DEXCOM, INC. |
| Owner/operator number | 9071756 |
| Premarket submissions | K261402 |
| Product codes | KGX, QBJ |
| Device names | KGX - Tape And Bandage, Adhesive, QBJ - Integrated Continuous Glucose Monitoring System, Factory Calibrated |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1355, 880.5240 |
| Review panels | Clinical Chemistry, General Hospital |
| Registered establishments | Dexcom, Inc., DEXCOM, INC., DEXCOM INTERNATIONAL LIMITED, Dexcom (Malaysia) Sdn. Bhd. |
| Establishment registrations | 3004753838, 3013435121, 3027503105, 3037326582 |
| FEI numbers | 3004753838, 3013435121, 3027503105, 3037326582 |
| Establishment operations | Complaint File Establishment, Specification Developer, Foreign Exporter, Manufacturer |
| 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