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Medefil's Heparin I.v. Flush Syringe, In Various Fill Sizes - 1 Ml Fill In 3 Ml…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K993518

by Medefil, Inc.

Identifiers

510(k) Number
K993518 FDA 510(k)
FDA Product Code
FOZ FDA 510(k)
Models / Variants
Medefil's Heparin I.v. Flush Syringe, In Various Fill Sizes - 1 Ml Fill In 3 Ml Syringe Ll FDA 510(k)
1 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)

The Medefil's Heparin I.V. Flush Syringe is a sterile, pre-filled syringe containing heparin solution, designed for flushing in-dwelling intravenous access devices (IVADs). It is available in various fill sizes, including 1 ml fill in 3 ml syringe LL and 1 ml fill in 6 ml syringe LL.

The device is supplied as a single-use, sterile product and is intended for use in clinical settings. It is not reusable and must be discarded after use. The device is regulated under FDA 510(k) clearance (K993518) and has a product code of FOZ.

Frequently asked questions

What is the Medefil Heparin I.V. Flush Syringe used for?

This device is a sterile, single-use syringe containing heparin solution. It is intended for flushing in-dwelling intravenous access devices (IVADs) to maintain patency.

What are the available sizes and fill volumes?

The syringe is available in two configurations: a 1 ml heparin fill in a 3 ml syringe LL, and a 1 ml heparin fill in a 6 ml syringe LL.

Is the syringe sterile and intended for single use?

Yes, the device is supplied as a sterile, single-use product. It must be discarded after use and is not reusable.

What is the regulatory status of this device?

The Medefil Heparin I.V. Flush Syringe is regulated under FDA 510(k) clearance (K993518) and has a product code of FOZ.

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: Heparin Lock Flush Syringe, 100 Units/ml - Medefil, Medefil'S Heparin I.v. Flush Syringe in Various Fill Sizes - 1 Ml Fill ..., Medefil'S Heparin I.v. Flush Syringe, in Various Fill Sizes - 1 Ml Fill ..., Medefil'S Heparin I.v. Flush Syringe, in Various Fill Sizes - 1 Ml Fill ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medefil, Inc.

Sources (1)

  • FDA 510(k) K993518 24 fields · synced Oct 6, 2026