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Found 3 results
510(k) Data Aggregation
K Number
K053169Device Name
RM3 RENAL PRESERVATION SYSTEM
Manufacturer
WATERS INSTRUMENTS, INC.
Date Cleared
2006-01-17
(64 days)
Product Code
KDK
Regulation Number
876.5880Why did this record match?
Applicant Name (Manufacturer) :
WATERS INSTRUMENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RM3 Renal Preservation System is intended to be used to maintain kidneys for transplant.
Device Description
The RM3 Renal Preservation System is a lightweight, transportable and self-contained renal preservation system, designed to support static monitoring and transportation of kidneys. The RM3 system provides controlled kidney perfusion of hypothermic physiologic solutions, and monitors, displays, trends, and saves important perfusion parameters, including: perfusate flow, temperature, pressure, and renal resistance. The RM3 system control unit can be configured to signal an audio and visual alarm for user-selected limits, and print user-selected data and waveforms.
The RM3 Renal Preservation System is a two-part system comprising a control unit for perfusion and monitoring of one or two kidneys, and a sterile, disposable single-use cassette used to contain and circulate perfusate to the kidneys.
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K Number
K042224Device Name
RM3 RENAL PRESERVATION SYSTEM
Manufacturer
WATERS INSTRUMENTS, INC.
Date Cleared
2004-10-22
(66 days)
Product Code
KDN
Regulation Number
876.5880Why did this record match?
Applicant Name (Manufacturer) :
WATERS INSTRUMENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RM3 Renal Preservation System is intended to be used to maintain kidneys for transplant.
Device Description
The RM3 Renal Preservation System is a lightweight, transportable and self-contained renal preservation system, designed to support static monitoring and transportation of kidneys. The RM3 system provides controlled kidney perfusion of hypothermic physiologic solutions, and monitors, displays, trends, and saves important perfusion parameters, including: perfusate flow, temperature, pressure, and renal resistance. The RM3 system control unit can be configured to signal an audio and visual alarm for user-selected limits, and print user-selected data and waveforms.
The RM3 Renal Preservation System is a two-part system comprising a control unit for perfusion and monitoring of one or two kidneys, and a sterile, disposable single-use cassette used to contain and circulate perfusate to the kidneys.
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K Number
K971571Device Name
RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT
Manufacturer
WATERS INSTRUMENTS, INC.
Date Cleared
1997-07-29
(90 days)
Product Code
KDN
Regulation Number
876.5880Why did this record match?
Applicant Name (Manufacturer) :
WATERS INSTRUMENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Waters Medical Systems (Waters Instruments, Inc.) RM3 Renal Preservation System is intended to be used to maintain kidneys for transplant.
Device Description
The RM3 Renal Preservation System is a lightweight, transportable and self-contained renal preservation system, designed to support static monitoring and transportation of kidneys. The RM3 system control unit provides controlled kidney perfusion of hypothermic physiologic solutions, and monitors, displays, trends, and saves important perfusion parameters, including; perfusate flow temperature, rate and pressure, and resistance. The RM3 system control unit can be configured to signal an audio and visual alarm for user-selected limits, and print user-selected data and waveforms.
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