VIAL2BAG

• • Terminated Z-0768-2019 FDA Class I ·initiated 26 Dec 2018

  Adverse events have been reported with the use of oxytocin in conjunction with the 13mm Vial2Bag DC in pregnant women. Vial2Bag is recalled due to similarities with 13mm Vial2Bag DC.

510(k) Number

K072759 ↗

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. →