K Number
K960581Device Name
SECURE EVA DUAL CHAMBER MIXING BAGManufacturer
Date Cleared
1996-04-30
(78 days)
Product Code
Regulation Number
880.5025Type
TraditionalPanel
HOReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
§ 880.5025 I.V. container.
(a)
Identification. An I.V. container is a container made of plastic or glass used to hold a fluid mixture to be administered to a patient through an intravascular administration set.(b)
Classification. Class II (performance standards).