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Maxplus Tru-Swab Positive Displacement Connector

by Medegen Medical Manufacturing System 2 variants

510(k) K072542

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 NumberK072542 Date25 Sep 2007ClearedStatusActive

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  • Withdrawn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)

510(k) Number
FDA Product Code
FPA
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

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

The Maxplus Tru-Swab Positive Displacement Connector is an intravascular administration set component designed for needleless access to intravenous lines and catheters. It facilitates essential clinical procedures during intravenous therapy, including priming, swabbing, and flushing.

This device is supplied sterile for single-patient use and is safe for use in MRI environments as it contains no metal. It is intended for use on all patients requiring intravenous therapy and has received FDA 510(k) clearance.

Other devices from Medegen Medical Manufacturing System

Questions

AI-generated answers, 26 Sep 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 primary function of the Maxplus Tru-Swab?

    The Maxplus Tru-Swab is a positive displacement connector used for needleless access to intravenous lines and catheters. It is designed to facilitate essential clinical procedures during intravenous therapy, including priming, swabbing, and flushing.

  • Is this device safe for use in an MRI environment?

    Yes, the Maxplus Tru-Swab is safe for use in MRI environments because it is constructed without any metal components, preventing interference with imaging equipment.

  • Is the Maxplus Tru-Swab intended for single or multiple use?

    This device is supplied sterile and is intended for single-patient use only. This ensures patient safety and maintains the integrity of the sterile barrier before the device is applied to an intravenous line.

  • What is the regulatory status of this connector?

    The Maxplus Tru-Swab Positive Displacement Connector has received FDA 510(k) clearance. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.