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Medefil's Normal Saline Flush Syringe In Various Fill Sizes - 1 Ml Fill In 6 Ml…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K020999

by Medefil, Inc.

Identifiers

510(k) Number
K020999 FDA 510(k)
FDA Product Code
NGT FDA 510(k)
Models / Variants
Medefil's Normal Saline Flush Syringe In Various Fill Sizes - 1 Ml Fill In 6 Ml Syringe Ll FDA 510(k)
2 Ml Fill In 6 Ml Syringe Ll 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)

Medefil's Normal Saline Flush Syringe in Various Fill Sizes is a vascular access flush device designed to maintain patency of indwelling intravenous access devices (IVAD). It is a sterile, single-use syringe prefilled with normal saline solution for intravenous flushing.

The device is supplied in two specific configurations: 1 ml fill in a 6 ml syringe with luer lock (LL) connection and 2 ml fill in a 6 ml syringe with luer lock (LL) connection. It is regulated under FDA 510(k) clearance K020999, classified as a Class II device with product code NGT, and intended for use in general hospital settings.

Frequently asked questions

What is Medefil's Normal Saline Flush Syringe used for?

It is designed to maintain patency of indwelling intravenous access devices by flushing IV lines with normal saline to prevent clot formation and ensure continued function.

How is Medefil's Normal Saline Flush Syringe supplied and what sizes are available?

It is supplied as a sterile, single-use syringe in two configurations: 1 ml of normal saline in a 6 ml luer lock syringe, or 2 ml of normal saline in a 6 ml luer lock syringe.

Is Medefil's Normal Saline Flush Syringe sterile and intended for single use only?

Yes, the device is sterile and labeled for single-use only to prevent contamination and ensure patient safety during intravenous flushing procedures.

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: Medefil'S Normal Saline Flush Syringe in Various Fill Sizes - 1 Ml Fill ..., Normal Saline I.V. Flush Syringes - Medefil, Medefil's Normal Saline Flush Syringe, In Various Fill Sizes - 1 Ml ..., PDF SALINE INSERT_Rev_005_a - Medefil, Inc

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medefil, Inc.

Sources (1)

  • FDA 510(k) K020999 24 fields · synced Sep 27, 2026