DORA Tubing Sets for Hemodialysis
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K161582 FDA 510(k)
- FDA Product Code
- FJK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5820 FDA 510(k)
- Regulation Number
- 876.5820 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The DORA Tubing Sets for Hemodialysis are classified as Set, Tubing, Blood, With and Without Anti-Regurgitation Valve, a medical device designed for use in hemodialysis procedures. These sets provide a sterile pathway for blood to circulate between the patient and the dialysis machine, ensuring safe and efficient filtration of blood through the hemodialysis system.
These tubing sets are intended for single-use in controlled clinical environments such as dialysis centers. Supplied sterile and packaged individually, they comply with regulatory standards including FDA 510K clearance and MDR conformity. The sets are available in multiple reference codes (e.g., 3002974635, 3032828299) to accommodate various hemodialysis configurations, with no MRI safety restrictions. Storage requires adherence to manufacturer guidelines to maintain sterility and functionality.
Frequently asked questions
Are these tubing sets reusable or designed for single-use only, and how should they be handled to maintain safety?
The DORA Tubing Sets for Hemodialysis are explicitly designed for single-use only in controlled clinical environments like dialysis centers. Since they are supplied sterile and packaged individually, they must remain unopened until use. After use, they should be discarded to prevent contamination or cross-infection, as reuse is not supported by the manufacturer’s design or regulatory compliance.
What sizes or models are available for the DORA Tubing Sets, and how do I determine which one fits my hemodialysis setup?
The DORA Tubing Sets come in multiple reference codes (e.g., 3002974635, 3032828299), each tailored to accommodate different hemodialysis configurations. While exact dimensions or flow specifications aren’t detailed here, the variety of codes suggests compatibility with standard blood circuit setups. Consulting the manufacturer’s product catalog or a dialysis specialist can help match the correct set to your machine’s requirements.
Do these tubing sets have any special features, like anti-regurgitation valves, and how might that affect their use?
Yes, the DORA Tubing Sets are available with or without anti-regurgitation valves, which prevent backflow of dialysate into the patient’s blood circuit. This feature reduces the risk of air embolism or contamination during the dialysis procedure. If your setup requires flow control, the valve-equipped sets are recommended for added safety.
How should I store these tubing sets to ensure they remain sterile and functional until use?
Storage must follow the manufacturer’s guidelines to preserve sterility and functionality. The sets should be kept in their original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid exposure to chemicals or contaminants, and check expiration dates before use, as prolonged storage may compromise integrity.
Are there any restrictions on using these tubing sets with medical imaging, like MRI scans, during hemodialysis?
No, the DORA Tubing Sets for Hemodialysis have no MRI safety restrictions listed in the documentation. This means they can be used in hemodialysis procedures without interference from MRI environments, though standard precautions for patient safety during imaging should still apply.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K161582 | Class II | Active |
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Manufacturer
- Manufacturer
- Bain Medical Equipment (Guangzhou) Co., Ltd.
Sources (2)
- FDA 510(k) K161582 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 26, 2026