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Found 6 results
510(k) Data Aggregation
K Number
K151728Device Name
CoStorSol plus G
Manufacturer
PRESERVATION SOLUTIONS, INC.
Date Cleared
2015-09-18
(84 days)
Product Code
KDN
Regulation Number
876.5880Why did this record match?
Applicant Name (Manufacturer) :
PRESERVATION SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CoStorSol® plus G is intended for the flushing and cold storage of liver, kidney, and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient.
Device Description
Preservation Solutions, Inc. manufacturers CoStorSol® plus G according to a "recipe" pioneered at the University of Wisconsin by Folkert O. Belzer, MD and James H. Southard, PhD. Indeed, this cold storage solution is often referred to as "Belzer UW" solution. The formulation includes soluble colloids, buffers, sodium and potassium salts, redox stabilizers, and phosphoric compounds.
CoStorSol® plus G is a clear to light yellow, sterile, non-pyrogenic solution for hypothermic flushing and storage of organs. The solution is packaged in 1-liter bags, to which 0.922 g of sterile glutathione may be added just prior to use. The solution must be chilled to between 2° and 6° C prior to use.
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K Number
K091245Device Name
COSTORSOL
Manufacturer
PRESERVATION SOLUTIONS, INC.
Date Cleared
2009-06-17
(50 days)
Product Code
KDN
Regulation Number
876.5880Why did this record match?
Applicant Name (Manufacturer) :
PRESERVATION SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CoStorSol® is intended for the flushing and cold storage of kidney, liver and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient.
Device Description
Preservation Solutions, Inc. manufacturers CoStorSol® according to a "recipe" pioneered at the University of Wisconsin by Folkert O. Belzer, MD and James H. Southard, PhD. Indeed, the cold storage solution is often referred to as "Belzer UW" solution. The formulation includes soluble colloids, buffers, sodium and potassium salts, redox stabilizers, and phosphoric compounds to aid tissue viability by enabling regeneration of adenosine triphosphate (ATP).
CoStorSol® is a clear to light yellow, sterile, non-pyrogenic solution for hypothermic flushing and storage of organs. The solution is packaged in 1-liter bags, which must be chilled to between 2° and 6° C prior to use. The solution may be used without any point of use filtration.
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K Number
K083453Device Name
COSTORSOL
Manufacturer
PRESERVATION SOLUTIONS, INC.
Date Cleared
2009-01-21
(61 days)
Product Code
KDN
Regulation Number
876.5880Why did this record match?
Applicant Name (Manufacturer) :
PRESERVATION SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CoStorSol® is intended for the flushing and cold storage of kidney, liver and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient
Device Description
Preservation Solutions, Inc manufacturers CoStorSol® according to a "recipe" proneered at the University of Wisconsin by Dr Folkert O Belzer Indeed, the cold storage solution is often referred to as "Belzer UW" solution The formulation includes soluble collords, buffers, sodium and potassium salts, redox stabilizers, and phosphoric compounds to and tissue vrability by enabling regeneration of adenosine triphosphate (ATP)
CoStorSol® is a clear to light yellow, sterile, non-pyrogenic solution for hypothermic flushing and storage of organs The solution is packaged in 1-liter bags
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K Number
K080432Device Name
MAPERSOL
Manufacturer
PRESERVATION SOLUTIONS, INC.
Date Cleared
2008-08-08
(171 days)
Product Code
KDN
Regulation Number
876.5880Why did this record match?
Applicant Name (Manufacturer) :
PRESERVATION SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MaPerSol® organ preservation solution is intended for in-vitro flushing and continuous hypothermic machine perfusion of explanted kidneys.
Device Description
Preservation Solutions, Inc. manufacturers MaPerSol® according to a "recipe" pioneered at the University of Wisconsin by Dr. Folkert O. Belzer and Dr. James Southard. The kidney flushing and perfusion storage solution may still be referred to as Belzer-MPS™, UW Machine Perfusion Solution, and is currently sold under that trade name (Trans-Med Corporation, Elk River, MN), as well as under the trade name KPS-1 (Organ Recovery Systems, Des Plaines, IL). The formulation includes soluble colloids, buffers, sodium and potassium salts, redox stabilizers, and compounds to aid tissue viability by enabling regeneration of adenosine triphosphate (ATP).
MaPerSol® is a colorless, sterile, non-toxic solution for in-vitro flushing and continuous perfusion of explanted kidnevs. The solution is packaged in 1-liter bags.
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K Number
K073693Device Name
COSTORSOL
Manufacturer
PRESERVATION SOLUTIONS, INC.
Date Cleared
2008-07-03
(185 days)
Product Code
KDN
Regulation Number
876.5880Why did this record match?
Applicant Name (Manufacturer) :
PRESERVATION SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CoStorSol® is intended for the flushing and cold storage of kidney, liver and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient.
Device Description
Preservation Solutions, Inc. manufacturers CoStorSol® according to a "recipe" pioneered at the University of Wisconsin by Dr. Folkert O. Belzer. The cold storage solution is still referred to as "Belzer UW" solution, even though it has been marketed under the trade name ViaSpan®. The formulation includes soluble colloids, buffers, sodium and postassium salts, redox stabilizers, and phosphoric compounds to aid tissue viability by enabling regeneration of adenosine triphosphate (ATP).
CoStorSol® is a clear to light yellow, sterile, non-pyrogenic solution for hypothermic flushing and storage of organs. The solution is packaged in 1-liter bags.
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K Number
K022826Device Name
CLEAR-IT ANTI-FOG, MODEL PS003
Manufacturer
PRESERVATION SOLUTIONS, INC.
Date Cleared
2002-10-09
(44 days)
Product Code
OCT
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
PRESERVATION SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Clear-It Anti-Fog Solution is indicated for use in the sterile surgical arena to eliminate condensation from endoscopic lenses, microscope lenses, goggles and other devices that are likely to fog.
Device Description
Clear-It Anti-Fog is a solution whose primary ingredients are Water, Isopropyl Alcohol, Sodium Alcohol Ether Sulfate, and Ammonium Dodecylbenzene proportionally mixed balanced and packaged according to approved manufacturing processes. Clear-It Anti-Fog is terminally sterilized by gamma irradiation. The appropriate dose was established using ISO 11137 method I protocol. Quarterly dose audits are performed using the same ISO 11137 protocol. Routine production testing prior to release includes pH, cytotoxicity, efficacy, and bacterial endotoxin.
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