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510(k) Data Aggregation
K Number
K153384Device Name
Low Potassium Dextran Solution with Tris Diluent
Manufacturer
Date Cleared
2016-02-19
(88 days)
Product Code
Regulation Number
876.5880Why did this record match?
Applicant Name (Manufacturer) :
United Therapeutics Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Low Potassium Dextran Solution with Tris Diluent is indicated for flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.
Device Description
Low Potassium Dextran (LPD) Solution is a sterile, clear, non-pyrogenic, physiological salt solution for hypothermic flushing, storage, and transportation of human lungs outside the human body. LPD Solution is acidic and is adjusted shortly before use to pH 7.4 by the addition of Tris Diluent.
LPD Solution with Tris Diluent is supplied as 1 liter of LPD Solution in a low density polyethylene (LDPE) bottle (8 per pack), co-packed with one single-use bottle of Tris Diluent. Tris Diluent is also supplied separately in an eight-unit pack. Each container of LPD Solution and Tris Diluent is single-use.
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