INJECTOR LUER - N34

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

510(k) Number

K092782 ↗

FDA Product Code

LHI

Models / Variants

N34

Injector Luer Lock

Model N35

Injector Luer Lock

N35C

Connector Luer Lock

Model C35

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Infusion Adapter C100

  Class II

  FDA 510(k) K110023 Active Cleared 12 Apr 2011

• Phaseal

  Class II

  FDA 510(k) K023747 Active Cleared 15 Nov 2002

• Phaseal, Closed System Forhandling of Parenteral Drugs, Additional Administration Devices. C80 Infusion Adapter, A10 Pro

  Class II

  FDA 510(k) K980381 Active Cleared 3 Mar 1998

• Protector 21, Protector 50, Protector 14, Injector Luer Lock, Infusion Adapter

  Class II

  FDA 510(k) K001368 Active Cleared 12 May 2000

• Phaseal - Closed System for the Preparation and Administration of Parenteral Drugs

  Class II

  FDA 510(k) K060866 Active Cleared 28 Apr 2006

• Phaseal Protector P14, P21, P28 and P50

  Class II

  FDA 510(k) K090634 Active Cleared 23 Mar 2009

• What are the Injector Luer and Connector Luer Lock used for?

  These devices are designed to function as part of the PhaSeal closed system drug transfer device. They are specifically indicated for the preparation and administration of parenteral medications.

• Are these devices intended for single-use or can they be reprocessed?

  These devices are intended for single-use only. They are designed to be used once and then discarded to maintain the integrity of the closed system and prevent potential contamination.

• Are the Injector Luer and Connector Luer Lock supplied sterile?

  Yes, these devices are supplied as sterile products. This ensures they are ready for use in clinical environments for the preparation and administration of parenteral drugs.

• What is the regulatory status of these devices?

  These devices have received FDA 510(k) clearance under K092782. This indicates that the devices have been determined to be substantially equivalent to legally marketed predicate devices.