Search Results
Found 3 results
510(k) Data Aggregation
K Number
K121736Device Name
PERF-GEN PULSATILE PERFUSION SOLUTION
Manufacturer
WATERS MEDICAL SYSTEMS, LLC
Date Cleared
2013-08-16
(429 days)
Product Code
KDL
Regulation Number
876.5880Why did this record match?
Applicant Name (Manufacturer) :
WATERS MEDICAL SYSTEMS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PERF-GEN® Pulsatile 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
The PERF-GEN® Pulsatile Perfusion (PERF-GEN Solution) is a clear, sterile, non-pyrogenic, non-toxic solution for the in-vitro flushing and temporary continuous perfusion of explanted kidneys. This solution has an approximate calculated osmolarity of 300 mOsm/kg, a sodium concentration of 100 mEq/L, a potassium concentration of 25 mEq/L, and a pH of approximately 7.4 at room temperature.
Ask a Question
K Number
K121618Device Name
BEL-GEN COLD STORAGE SOLUTION
Manufacturer
WATERS MEDICAL SYSTEMS, LLC
Date Cleared
2013-06-14
(378 days)
Product Code
KDL, KDN
Regulation Number
876.5880Why did this record match?
Applicant Name (Manufacturer) :
WATERS MEDICAL SYSTEMS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BEL-GEN® Cold Storage Solution is intended for the flushing and the hypothermic 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
The BEL-GEN® Cold Storage Solution (BEL-GEN Solution) is clear to light yellow, sterile and pyrogen-free solution. BEL-GEN Solution has an approximate osmolality of 320 mOsm/kg, a sodium concentration of 29 mmol/L, a potassium concentration of 125 mmol/L and a pH of 7.4 at 20°C.
Ask a Question
K Number
K111521Device Name
WAVES
Manufacturer
WATERS MEDICAL SYSTEMS, LLC
Date Cleared
2012-02-16
(260 days)
Product Code
KDN
Regulation Number
876.5880Why did this record match?
Applicant Name (Manufacturer) :
WATERS MEDICAL SYSTEMS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The WAVES is intended to be used for the pulsatile hypothermic machine perfusion of kidneys for preservation, transportation, and eventual transplantation into a recipient.
Device Description
The WAVES is a transportable, self-contained renal preservation system, designed to support static monitoring and transportation of kidneys. The WAVES system provides controlled pulsatile kidney perfusion using oxygenated hypothermic physiologic solutions, and monitors, displays, trends, and saves important perfusion parameters, including: perfusate flow, temperature, pressure, and renal resistance. The WA VES system can be configured to signal an audio and visual alarm for user-selected limits.
The WAVES is a two-part system comprising a 'control unit' for perfusion and monitoring of a single kidney, and a sterile, single-use, disposable 'cassette module' used to contain, refrigerate, and circulate perfusate to and through the kidney.
Ask a Question
Page 1 of 1