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Heparin Lock Flush Syringe

by Am2 Pat, Inc.

510(k) K032417

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK032417 Date23 Dec 2003ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0827-2008 FDA Unclassified (pre-2012) initiated 11 Dec 2007

    Lack of assurance of sterility by manufacturer

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FOZ
Device Class
Class II
Regulation
21 CFR Part 880.5200
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Heparin Lock Flush Syringe is a sterile, single-use, pre-filled piston-type syringe containing 10 or 100 USP u/ml Heparin Lock Flush Solution. It is intended for prescription use to flush compatible intravenous administration sets and indwelling intravascular access devices. Components include a polypropylene barrel and polypropylene plunger.

The device is supplied as a pre-filled syringe and is for single-use only. It is regulated under FDA 510(k) clearance with product code FOZ and K-number K032417. The device should be stored according to manufacturer instructions and is available in multiple sizes including 5 mL in 12 mL syringes.

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Heparin Lock Flush Syringe used for?

    The Heparin Lock Flush Syringe is intended for prescription use to flush compatible intravenous administration sets and indwelling intravascular access devices. It helps maintain patency of these devices.

  • Is the Heparin Lock Flush Syringe reusable or single-use?

    The Heparin Lock Flush Syringe is designed for single-use only. It should not be reused as it is a sterile, pre-filled piston-type syringe intended for one-time use to maintain sterility and prevent contamination.

  • What sizes are available for the Heparin Lock Flush Syringe?

    The Heparin Lock Flush Syringe is available in multiple sizes, including 5 mL in 12 mL syringes, with concentrations of 10 or 100 USP u/ml Heparin Lock Flush Solution. The specific size needed depends on clinical requirements.

  • How should the Heparin Lock Flush Syringe be stored?

    The Heparin Lock Flush Syringe should be stored according to the manufacturer's instructions to maintain its integrity and sterility. Proper storage conditions help ensure the product remains effective until its expiration date.