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Sign in to claim this brandPOIESIS MEDICAL, LLC
US
Last updated May 30, 2026
What POIESIS MEDICAL, LLC makes
Poiesis Medical, LLC manufactures indwelling urethral catheterization kits and non-antimicrobial drainage balloon catheters for adult use. Their products include single-lumen and dual-balloon catheters, with some featuring temperature-sensing capabilities and 100% silicone construction. These devices are designed for short- and long-term urinary drainage applications.
The company’s portfolio consists of Class II medical devices, regulated under the FDA’s 510(k) and Unique Device Identification (UDI) programs. Their products are listed in the FDA’s regulatory databases, and the manufacturer operates from 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 Poiesis Medical, LLC manufacture?
Poiesis Medical, LLC specializes in indwelling urethral catheterization kits and non-antimicrobial drainage balloon catheters designed for adult use. Their products include both single-lumen and dual-balloon catheters, such as the Duette™ line, which may feature additional functionalities like temperature sensing or 100% silicone construction. These devices are intended for short- and long-term urinary drainage.
Where is Poiesis Medical, LLC based?
Poiesis Medical, LLC is based in the United States. The company’s headquarters and operations are located within the country, though specific regional offices or manufacturing sites are not detailed in the available information.
Which regulatory registries or databases list Poiesis Medical, LLC’s devices?
Poiesis Medical, LLC’s devices are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identification (UDI) system. These registries ensure traceability and compliance tracking for Class II medical devices, which are subject to stricter regulatory oversight than Class I devices.
How are Poiesis Medical, LLC’s devices classified under medical device regulations?
Poiesis Medical, LLC’s devices fall under Class II classification in the FDA’s regulatory framework. This classification applies to devices that pose moderate risk and require special controls—such as performance standards or post-market surveillance—to ensure safety and effectiveness. Class II devices are subject to the 510(k) premarket submission process.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- poiesismedical.com
- —
- —
- [email protected]
- Phone
- +1(877)487-5740
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 831415109
Catalogue (12)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Duette™ | D-10018 | FDA UDI | Class II | Active |
| Duette™ | K-10016U | FDA UDI | Class II | Active |
| Duette™ | K-10014U | FDA UDI | Class II | Active |
| Duette™ | K-10016UT | FDA UDI | Class II | Active |
| Duette™ | D-10014 | FDA UDI | Class II | Active |
| Duette™ | K-10018UT | FDA UDI | Class II | Active |
| Duette™ | K-10018U | FDA UDI | Class II | Active |
| Duette™ | K-10016 | FDA UDI | Class II | Active |
| Duette™ | D-10016 | FDA UDI | Class II | Active |
| Duette™ | K-10014 | FDA UDI | Class II | Active |
| Duette™ | K-10018 | FDA UDI | Class II | Active |
| Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter | K173533 | FDA 510(k) | Class II | Active |
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