Praxiject 0.9% NaCl
FDA 510(k)Class II (US FDA 510(k))
by MedXL Inc
Identifiers
- 510(k) Number
- K231754 FDA 510(k)
- FDA Product Code
- NGT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5200 FDA 510(k)
- Regulation Number
- 880.5200 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Praxiject 0.9% NaCl is a saline vascular access flush device. It is designed for use as an intravenous flush to maintain the patency of vascular access devices.
This device is supplied as a prefilled syringe and is intended for single use only. It is sterile unless the package is opened or damaged and must not be resterilized. The product has received FDA 510(k) clearance.
Frequently asked questions
What is the primary purpose of the Praxiject 0.9% NaCl device?
This device is specifically designed as an intravenous flush to maintain the patency of vascular access devices, ensuring they remain clear and functional for clinical use.
Is the Praxiject 0.9% NaCl syringe intended for reuse?
No, this device is intended for single use only. It must be discarded after the initial application to prevent contamination and ensure patient safety.
How is the sterility of the device maintained?
The device is supplied as a sterile product. It remains sterile unless the packaging is opened or damaged. It must not be resterilized under any circumstances, as this could compromise the integrity of the device.
What is the regulatory status of this device?
Praxiject 0.9% NaCl has received FDA 510(k) clearance, confirming it has been reviewed and found to be substantially equivalent to legally marketed predicate devices.
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: PDF Praxiject™ 0.9% NaCl - Food and Drug Administration, PDF Fs-VM-26_01e_Usage Guidelines_illustrated_Praxiject_DRAFT - medxl.com, K231754 FDA 510 (k) - Praxiject 0.9% NaCl | Medxl, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231754 | Class II | Active |
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Manufacturer
- Manufacturer
- MedXL Inc
- FDA Applicant
- Medxl, Inc.
Sources (1)
- FDA 510(k) K231754 24 fields · synced Sep 24, 2026