Search Results
Found 1 results
510(k) Data Aggregation
K Number
K101412Device Name
EVA TPN BAG
Manufacturer
VALMED S.R.L.
Date Cleared
2011-04-13
(328 days)
Product Code
KPE
Regulation Number
880.5025Why did this record match?
Applicant Name (Manufacturer) :
VALMED S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EVA TPN bag is for use in compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set.
Device Description
The EVA TPN bags are empty containers for use in compounding and storage of sterile medical solutions such as parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set. The empty bags are filled by connecting them to containers through standard spikes. A transfer set in different configurations, ranging from one-lead to three-lead sets, can be provided with the empty bag. The bags are clamped after filling by means of non-reopening clamps. Additional medications can be added to the container using a medication port. After filling, the containers can be attached to an intravascular administration set via the set port. The bags range in volume capacity from 150 mL to 5000 mL. The bag is discarded after use. The EVA TPN bags are made of a copolymer of ethylene and vinyl acetate. The tubings of the transfer set are made of a polyvinyl chloride material.
Ask a Question
Page 1 of 1