FDA device listing
Blood Pressure Cuffs- Balanced Nylon Bladders and accessories,Omni cuffs and accessories
FDA device listing 1228489391 · BAXTER HEALTHCARE CORPORATION
Key facts
| Proprietary names | Blood Pressure Cuffs- Balanced Nylon Bladders and accessories,Omni cuffs and accessories |
|---|---|
| Owner/operator | BAXTER HEALTHCARE CORPORATION |
| Owner/operator number | 1417572 |
| Premarket submissions | K930604 |
| Product codes | DXQ |
| Device names | DXQ - Blood Pressure Cuff |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1120 |
| Review panels | Cardiovascular |
| Registered establishments | WELCH ALLYN DE MEXICO, S. DE R.L. DE C.V., WELCH ALLYN, INC. |
| Establishment registrations | 1316463, 3006087789 |
| FEI numbers | 1316463, 3006087789 |
| Establishment operations | Contract Manufacturer, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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