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Injector Luer, Model N34, Injector Luer Lock, Model N35, Injector Luer Lock, N35C, Connector Luer Lock, Model C35,

by Carmel Pharma Ab.

510(k) K092782

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 NumberK092782 Date7 Dec 2009ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 27 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 Injector Luer and Connector Luer Lock are sterile devices used within the PhaSeal closed system drug transfer device. They are designed for the preparation and administration of parenteral drugs.

These devices are intended for single-use. This product has received FDA 510(k) clearance under K092782.

Other devices from Carmel Pharma Ab.

Questions

AI-generated answers, 27 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 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.