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Sign in to claim this brandUnited Therapeutics Corporation
US
Last updated May 24, 2026
What United Therapeutics Corporation makes
United Therapeutics Corporation manufactures electronic ambulatory non-insulin infusion pumps, including the Remunity and RemunityPRO models, designed for continuous subcutaneous delivery of therapeutic agents. The company also produces benchtop therapeutic agent nebulizers, such as Tyvaso, which administers inhaled medications for respiratory conditions.
The company’s devices are classified as Class II under FDA regulations and are listed via 510(k) premarket notifications and the Unique Device Identifier (UDI) system. These products are authorised for use in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does United Therapeutics Corporation manufacture?
United Therapeutics Corporation specializes in two primary device categories: ambulatory non-insulin infusion pumps and benchtop therapeutic agent nebulizers. The infusion pumps, such as the Remunity and RemunityPRO models, are electronic devices designed for continuous subcutaneous delivery of therapeutic agents. The benchtop nebulizer, Tyvaso, is used to administer inhaled medications for respiratory conditions. These devices are developed to address specific patient needs in chronic disease management.
Where is United Therapeutics Corporation based?
United Therapeutics Corporation is headquartered in the United States. While the exact location is not specified, the company’s regulatory filings and device authorizations are tied to the FDA’s jurisdiction in the US, indicating its primary operational base is within the country.
Which regulatory registries or databases list United Therapeutics Corporation’s devices?
United Therapeutics Corporation’s devices are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries are used to track and authorize medical devices in the United States, ensuring compliance with regulatory requirements for Class II devices.
How are United Therapeutics Corporation’s devices classified under FDA regulations?
United Therapeutics Corporation’s devices are classified as Class II under FDA regulations. This classification is determined based on the level of risk associated with the device. Class II devices generally require special controls in addition to general controls to ensure their safety and effectiveness, and they are authorized through processes like the 510(k) pathway.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- unither.com
- —
- —
- [email protected]
- Phone
- 877-864-8437
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 015718364
Catalogue (13)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Remunity | DKPI-11038-001 | FDA UDI | Class II | Active |
| RemunityPRO | DKUT-10008-001 | FDA UDI | Class II | Active |
| RemunityPRO | DKUT-21135-001 | FDA UDI | Class II | Active |
| RemunityPRO | DKUT-10007-001 | FDA UDI | Class II | Active |
| RemunityPRO | DKUT-21134-001 | FDA UDI | Class II | Active |
| Remunity | DKPI-21128-001 | FDA UDI | Class II | Active |
| RemunityPRO | DKUT-11029-007 | FDA UDI | Class II | Active |
| RemunityPRO | DKUT-21073-007 | FDA UDI | Class II | Active |
| RemunityPRO | DKUT-10006-001 | FDA UDI | Class II | Active |
| Remunity | DKPI-11036-001 | FDA UDI | Class II | Active |
| Tyvaso | TD-300/A | FDA UDI | Class II | Active |
| Remunity | DKPI-11042-001 | FDA UDI | Class II | Active |
| Low Potassium Dextran Solution with Tris Diluent | K153384 | FDA 510(k) | Class II | Active |
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