BD Syringe NRFit Lok and BD Syringe NRFit Slip
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K192538 FDA 510(k)
- FDA Product Code
- QEH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5860 FDA 510(k)
- Regulation Number
- 880.5860 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BD Syringe NRFit Lok and BD Syringe NRFit Slip are piston syringes with neuraxial connectors, designed for epidural, peripheral, and indirect cerebrospinal fluid contact procedures. These syringes feature a specialized connector system (NRFit) that ensures compatibility with neuraxial applications while preventing unintended connections to non-neuraxial devices, enhancing procedural safety.
These syringes are single-use medical devices and are supplied sterile, adhering to ISO 80369-6 standards for small-bore connectors. Available in 3 mL and 50 mL sizes, they are intended for use in general hospital settings and have received FDA 510(k) clearance (K192538) under the General Hospital advisory committee. Storage and handling must comply with sterile medical device protocols to maintain integrity.
Frequently asked questions
What types of medical procedures are these syringes designed for, and why is the NRFit connector system important?
The BD Syringe NRFit Lok and BD Syringe NRFit Slip are specifically designed for epidural, peripheral, and indirect cerebrospinal fluid contact procedures. The NRFit connector system ensures compatibility only with neuraxial applications, preventing accidental connections to non-neuraxial devices, which enhances procedural safety by reducing the risk of cross-contamination or misconnections.
Are these syringes reusable or single-use, and how should they be stored to maintain sterility?
These syringes are single-use only, as explicitly stated in the device description. To maintain sterility, they must be stored and handled according to standard sterile medical device protocols, ensuring the packaging remains intact until use.
What sizes are available, and how do I know which one to choose for my procedure?
The syringes come in 3 mL and 50 mL volumes. The choice depends on the procedural requirements—smaller volumes (3 mL) are typically used for precise dosing or smaller volumes of fluids, while larger volumes (50 mL) may be needed for bulk administration or flushing procedures.
How do I confirm these syringes meet regulatory standards for sterility and compatibility?
These syringes are supplied sterile and comply with ISO 80369-6 standards for small-bore connectors, ensuring safe use in neuraxial applications. They also hold FDA 510(k) clearance (K192538) under the General Hospital advisory committee, confirming their regulatory compliance for hospital settings.
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: BD Plastic NRFit Syringes | BD, PDF BD Syringes NRFit Slip and NRFit Lok BD®, BD® NRFit™ Needles and Syringes, BD (company) - Wikipedia, BD Syringe NRFit Lok and BD Syringe NRFit Slip (K192538) — FDA 510(k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192538 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K192538 24 fields · synced Oct 6, 2026