Imed Gemini 12 Nonvented Y-Type Blood/Solution Adm

• • Terminated Z-1770-2019 FDA Class I ·initiated 6 May 2019

  An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment of the affected infusion sets used with the. The issue has the potential to lead to unintended delivery of medication when the pump module is not in running status or can result in faster than expected drug delivery flow when the pump is infusing.

• • Terminated Z-0385-2019 FDA Class II ·initiated 20 Apr 2018

  Complaints where users were unable to prime the administration set.

510(k) Number

K894842 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K953896 Active Cleared 20 Mar 1996

• Macrodot Add-I-Med Admin. Set

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  FDA 510(k) K823347 Active Cleared 24 Nov 1982

• Imed(R) Gemini(Tm) Pc-1 Volumetric Infusion Pump

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• IV Filterset 5 Micrometer

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  FDA 510(k) K813445 Active Cleared 5 Jan 1982

• Imed Accuset Cassette

  Class II

  FDA 510(k) K812035 Active Cleared 28 Jul 1981

• Vented/Nonvented Gemini Administration Set with Check Valve and Two Safsite(Tm) Valves

  Class II

  FDA 510(k) K950153 Active Cleared 24 Aug 1995

See all devices from Imed Corp. →