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Double-Ject Transfer Needle

by Medimix Products, Inc.

510(k) K860113

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 NumberK860113 Date12 Feb 1986ClearedStatusActive

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  • Withdrawn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
LHI
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Double-Ject Transfer Needle is a Set, I.V. Fluid Transfer (FDA Product Code LHI), designed for the safe and efficient transfer of intravenous fluids between containers. Its dual-lumen design allows simultaneous infusion and withdrawal, reducing the risk of contamination and improving workflow in clinical settings.

This device is intended for single-use in general hospital environments and has been cleared under FDA 510(k) K860113 as substantially equivalent to predicate technology. Supplied sterile, it requires no additional processing before use and must be discarded after one application to maintain aseptic conditions. No MRI safety information is specified.

Other devices from Medimix Products, Inc.

Questions

AI-generated answers, 19 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 purpose of the Double-Ject Transfer Needle in a clinical setting?

    The Double-Ject Transfer Needle is designed specifically for transferring intravenous fluids between containers. Its dual-lumen design enables simultaneous infusion and withdrawal, which helps minimize contamination risks and streamlines workflow in hospital environments.

  • Is the Double-Ject Transfer Needle intended for reuse, or is it meant to be used only once?

    The device is explicitly intended for single-use only. After one application, it must be discarded to maintain aseptic conditions, as reuse could compromise sterility and patient safety.

  • How is the Double-Ject Transfer Needle supplied, and does it require any preparation before use?

    The needle is supplied sterile and ready for immediate use—no additional processing or sterilization is required. Simply attach it to the IV containers, perform the transfer, and then discard it.

  • What types of clinical environments is this device cleared for, and does it have any special safety considerations?

    The Double-Ject Transfer Needle is cleared for use in general hospital environments and is not intended for MRI settings (no MRI safety information is provided). Its dual-lumen design reduces contamination risks during fluid transfers.