NovaLine SP-C35 Transducer Protector (956007)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K240164 FDA 510(k)
- FDA Product Code
- FIB 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 NovaLine SP-C35 Transducer Protector (956007) is a protector, transducer designed to safeguard pressure monitors and prevent contamination of fluid pathways in hemodialysis delivery systems. Constructed as a single-use, disposable device, it features a plastic housing with a hydrophobic 0.2 µm PTFE composite membrane filter to ensure sterile fluid flow. Its design incorporates male/female luer lock connectors for secure attachment to monitoring equipment, mitigating cross-contamination risks during medical procedures.
This device is intended for use in gastroenterology and urology settings and is classified as a Class 2 medical device under FDA product code FIB. Supplied as a sterile, single-use item, it requires no reprocessing and must be discarded after one use. The device has received FDA 510(k) clearance via the Traditional pathway, adhering to regulatory standards for hemodialysis-related accessories. Storage conditions are not specified but should follow standard medical device protocols to maintain sterility and integrity.
Frequently asked questions
What is the NovaLine SP-C35 Transducer Protector (956007) used for?
The NovaLine SP-C35 Transducer Protector (956007) is designed to safeguard pressure monitors and prevent contamination of fluid pathways in hemodialysis delivery systems. Its primary function is to maintain sterile fluid flow by filtering out particles and pathogens, reducing the risk of cross-contamination during medical procedures in gastroenterology and urology settings.
How is the NovaLine SP-C35 Transducer Protector (956007) supplied and what are its key features?
The device is supplied as a sterile, single-use, disposable item. It features a plastic housing with a hydrophobic 0.2 µm PTFE composite membrane filter, ensuring sterile fluid flow. The design includes male/female luer lock connectors for secure attachment to monitoring equipment, which helps mitigate cross-contamination risks during use.
Is the NovaLine SP-C35 Transducer Protector (956007) reusable or single-use?
The NovaLine SP-C35 Transducer Protector (956007) is explicitly designed for single-use only. After one use, it must be discarded to prevent contamination and maintain sterile conditions, as it is not intended for reprocessing or reuse.
What storage conditions should be followed for the NovaLine SP-C35 Transducer Protector (956007)?
While specific storage conditions are not detailed in the device description, it is recommended to follow standard medical device protocols to preserve sterility and structural integrity. This typically includes storing in a clean, dry environment away from direct sunlight or extreme temperatures until use.
What regulatory pathway was followed for FDA clearance of the NovaLine SP-C35 Transducer Protector (956007)?
The device received FDA 510(k) clearance through the Traditional pathway, which is a standard route for demonstrating substantial equivalence to a legally marketed predicate device. This clearance confirms compliance with regulatory standards for hemodialysis-related accessories.
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. Sources consulted: NovaLine SP-C35 Transducer Protector (956007) (K240164) — FDA 510 (k ..., K240164 - NovaLine SP-C35 Transducer Protector (956007), NovaLine SP-C35 Transducer Protector (956007) - FDA 510(k) K240164
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240164 | Class II | Active |
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Manufacturer
- Manufacturer
- Bain Medical Equipment (Guangzhou) Co., Ltd.
Sources (1)
- FDA 510(k) K240164 24 fields · synced Oct 5, 2026