VIAL2BAG Direct Connect

• • Terminated Z-0972-2018 FDA Class II ·initiated 6 Oct 2017

  Medimop is recalling certain lots of this product Vial2Bag DC due to the potential of the IV Port separating from the Via12Bag DC body during the drug reconstitution I IV Set attachment process.

510(k) Number

K140730 ↗

FDA Product Code

LHI

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Vial Connector 13mm Closed Collar

  Class II

  FDA 510(k) K132040 Active Cleared 31 Jul 2013

• Modification to Mixject Dispensing Pin/with Detachable Vial Holder/with Detachable Vial Holder and Pre-Attached Needle

  Class II

  FDA 510(k) K001293 Active Cleared 5 May 2000

• MIX2VIAL Transfer Device

  Class II

  FDA 510(k) K031861 Active Cleared 29 Jul 2003

• Vial Adapter 15mm

  Class II

  FDA 510(k) K171796 Active Cleared 12 Oct 2017

• Vial2Bag Direct Connect

  Class II

  FDA 510(k) K170095 Active Cleared 8 Mar 2017

• Mixject Dispensing Pin/with Detachable Vial Holder/with Detachable Vial Holder and Preattached Needle

  Class II

  FDA 510(k) K963583 Active Cleared 7 Oct 1996

See all devices from Medimop Medical Projects, Ltd. →