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BD Preefile Normal Saline Flush Syringe

by Bd/Preefil

510(k) K982558

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK982558 Date8 Mar 2000ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Bd Preefile Normal Saline Flush Syringe Flush Syringe
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 BD Preefile Normal Saline Flush Syringe is a sterile, plastic, Luer-lock syringe pre-filled with 0.9% USP sodium chloride. It is used by healthcare providers to flush vascular access devices to maintain patency.

The syringe is supplied in sterile path and externally sterile packaged formats. It is a single-use device and is MRI safe. The device is FDA 510K cleared with product code FOZ and K-number K982558.

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 BD Preefile Normal Saline Flush Syringe used for?

    The BD Preefile Normal Saline Flush Syringe is used by healthcare providers to flush vascular access devices to maintain patency, ensuring proper function and preventing blockages.

  • Is the BD Preefile Normal Saline Flush Syringe single-use or reusable?

    The BD Preefile Normal Saline Flush Syringe is designed as a single-use device, meaning it should be discarded after one use to ensure sterility and prevent cross-contamination.

  • What are the specifications of the BD Preefile Normal Saline Flush Syringe?

    The syringe is sterile, plastic, and features a Luer-lock design. It is pre-filled with 0.9% USP sodium chloride and is MRI safe. It is FDA 510K cleared with product code FOZ and K-number K982558.

  • How is the BD Preefile Normal Saline Flush Syringe supplied?

    The syringe is supplied in both sterile path and externally sterile packaged formats, ensuring it remains sterile until use by healthcare providers.