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510(k) Data Aggregation
K Number
K091656Device Name
SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L
Manufacturer
ORGAN RECOVERY SYSTEMS, INC.
Date Cleared
2010-03-11
(275 days)
Product Code
KDL
Regulation Number
876.5880Why did this record match?
Applicant Name (Manufacturer) :
ORGAN RECOVERY SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SPS-1TM 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
SPS-1 TM is a clear to light yellow, sterile, non-pyrogenic solution for hypothermic flushing and storage of organs. The solution has an approximate calculated osmolality of 320 mOsm, a sodium concentration of 29 mEq/L, a potassium concentration of 125 mEq/L, and a pH of approximately 7.4 at 20°C.
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K Number
K021362Device Name
LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR)
Manufacturer
ORGAN RECOVERY SYSTEMS, INC.
Date Cleared
2003-07-31
(457 days)
Product Code
KDN
Regulation Number
876.5880Why did this record match?
Applicant Name (Manufacturer) :
ORGAN RECOVERY SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LifePort™, Kidney Perfusion Transporter (KTR) is intended to be used for the continuous hypothermic machine perfusion of kidneys for the preservation, transportation and eventual transplantation into a recipient.
Device Description
Not Found
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K Number
K022391Device Name
MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION
Manufacturer
ORGAN RECOVERY SYSTEMS, INC.
Date Cleared
2002-10-21
(90 days)
Product Code
KDN
Regulation Number
876.5880Why did this record match?
Applicant Name (Manufacturer) :
ORGAN RECOVERY SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
KPS-1™, The Kidney Perfusion Solution is intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor, in preparation for storage, transportation and eventual transplantation into a recipient.
Device Description
KPS-1™, The Kidney Perfusion Solution (UW Machine Perfusion Solution) is a clear, sterile, non-pyrogenic, non-toxic solution for the invitro flushing and temporary continuous perfusion preservation of explanted kidneys. This solution has an approximate calculated osmolarity of 300mOsM, a sodium concentration of 100mEq/L, a potassium concentration of 25mEq/L, and a pH of approximately 7.4 at room temperature. Based upon the sodium/potassium ratio, the composition is thus consistent with that of an extracellular solution.
KPS-1™ should be cooled to about 5°C (4°C to 8°C) prior to use and should be used in a perfusion machine that is capable of maintaining temperature within the above specified range.
It is recommended that the KPS-1™ be stored between 2 °C and 8 °C. The solution should not be frozen or exposed to excessive heat.
KPS-1™, The Kidney Perfusion Solution is suitable for a mean perfusion time of 29 hours +/~ 8 hours.
KPS-1™ The Kidney Perfusion Solution shelf-life is 6 months from data of aseptic fill. The stability of the perfusion solution was verified by accelerated aging for 6 months equivalency.
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K Number
K013575Device Name
KPS-I, THE KIDNEY PERFUSION SOLUTION
Manufacturer
ORGAN RECOVERY SYSTEMS, INC.
Date Cleared
2002-01-25
(88 days)
Product Code
KDN
Regulation Number
876.5880Why did this record match?
Applicant Name (Manufacturer) :
ORGAN RECOVERY SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
KPS-I™, The Kidney Perfusion Solution is intended to be used for in-vitro flushing and temporary continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor, in preparation for storage, transportation and eventual transplantation into a recipient.
Device Description
KPS-I™, The Kidney Perfusion Solution (UW Machine Perfusion Solution) is a clear, sterile, non-pyrogenic, non-toxic solution for the invitro flushing and temporary continuous perfusion preservation of explanted kidneys. This solution has an approximate calculated osmolarity of 300mOsM, a sodium concentration of 100mEq/L, a votassium concentration of 25mEg/1, and a pH of approximately 7.4 at room temperature. Based upon the sodium/potassium ratio, the composition is thus consistent with that of an extracellular solution.
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