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Sign in to claim this brandResp Devices LLC
US
Last updated May 27, 2026
What Resp Devices LLC makes
Resp Devices LLC manufactures single-use tracheostomy tube neck holders designed to secure tracheostomy tubes in place for patients requiring long-term airway management. These devices are intended to reduce the risk of accidental dislodgement while maintaining stability and ease of use during medical procedures.
The company’s portfolio is classified under FDA’s Class I medical devices and is listed in the FDA’s Unique Device Identifier (UDI) database. Resp Devices LLC operates from the United States, adhering to applicable regulatory requirements for these low-risk devices.
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 Resp Devices LLC manufacture?
Resp Devices LLC specializes in single-use tracheostomy tube neck holders. These devices are specifically designed to secure tracheostomy tubes in place for patients who need long-term airway management, helping to minimize the risk of accidental dislodgement while ensuring stability and ease of use during medical care.
Where is Resp Devices LLC based, and does its location affect its regulatory compliance?
Resp Devices LLC is based in the United States. Since its devices fall under FDA’s regulatory jurisdiction, the company operates within U.S. regulatory requirements, which include compliance with applicable standards for Class I medical devices. The U.S. location ensures adherence to domestic regulations governing device safety and performance.
Which regulatory registries or databases list Resp Devices LLC’s devices?
Resp Devices LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices like tracheostomy tube neck holders, ensuring transparency and traceability in the healthcare supply chain.
How are Resp Devices LLC’s devices classified under FDA regulations?
Resp Devices LLC’s tracheostomy tube neck holders are classified as Class I medical devices by the FDA. This classification is typically assigned to low-risk devices that pose minimal potential harm to patients, allowing for streamlined regulatory oversight while still ensuring compliance with safety and performance standards.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- [email protected]
- Phone
- 917-299-1512
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 104305239
Catalogue (14)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Dr Zee | 8001 | FDA UDI | Class I | Active |
| Dr Zee | 8006 | FDA UDI | Class I | Active |
| Dr Zee | 8017 | FDA UDI | Class I | Active |
| Dr Zee | 6240 | FDA UDI | Class I | Active |
| Dr Zee | 8015 | FDA UDI | Class I | Active |
| Dr Zee | 8003 | FDA UDI | Class I | Active |
| Dr Zee | 6003 | FDA UDI | Class I | Active |
| Dr Zee | 6001 | FDA UDI | Class I | Active |
| Dr Zee | 8016 | FDA UDI | Class I | Active |
| Dr Zee | 6241 | FDA UDI | Class I | Active |
| Dr Zee | 8005 | FDA UDI | Class I | Active |
| Dr Zee | 8002 | FDA UDI | Class I | Active |
| Dr Zee | 8000 | FDA UDI | Class I | Active |
| Dr Zee | 6002 | FDA UDI | Class I | Active |
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