FDA device listing
Maximus System,Optimus,Synclara Cough System,Volara System
FDA device listing 1912065477 · BAXTER HEALTHCARE CORPORATION
Key facts
| Proprietary names | Maximus System,Optimus,Synclara Cough System,Volara System |
|---|---|
| Owner/operator | BAXTER HEALTHCARE CORPORATION |
| Owner/operator number | 1417572 |
| Premarket submissions | K192143 |
| Product codes | NHJ |
| Device names | NHJ - Device, Positive Pressure Breathing, Intermittent |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.5905 |
| Review panels | Anesthesiology |
| Registered establishments | HILL-ROM MANUFACTURING, INC., Hill-Rom Services Private Limited, WELCH ALLYN DE MEXICO, S. DE R.L. DE C.V. |
| Establishment registrations | 2183816, 3006087789, 3008145987 |
| FEI numbers | 2183816, 3006087789, 3008145987 |
| Establishment operations | Complaint File Establishment, Specification Developer, Contract Manufacturer, Manufacturer, 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