FDA device listing
0668 Cellular Blood Pressure Monitor with XL Cuff,0669 Cellular Blood Pressure Monitor with Standard Cuff,0677 Cellular…
FDA device listing 1192170018 · Greater Goods, LLC / Design Manufacture Distribution LLC
Key facts
| Proprietary names | 0668 Cellular Blood Pressure Monitor with XL Cuff,0669 Cellular Blood Pressure Monitor with Standard Cuff,0677 Cellular Blood Pressure Monitor with XL Cuff,0678 Cellular Blood Pressure Monitor with Standard Cuff |
|---|---|
| Owner/operator | Greater Goods, LLC / Design Manufacture Distribution LLC |
| Owner/operator number | 10047365 |
| Premarket submissions | K241351 |
| Product codes | DXN |
| Device names | DXN - System, Measurement, Blood-Pressure, Non-Invasive |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1130 |
| Review panels | Cardiovascular |
| Registered establishments | Greater Goods, LLC |
| Establishment registrations | 3011065399 |
| FEI numbers | 3011065399 |
| Establishment operations | Complaint File Establishment, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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