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510(k) Data Aggregation
K Number
K003582Device Name
FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-01
Manufacturer
Date Cleared
2000-12-05
(15 days)
Product Code
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
FLUIDSENSE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K982170Device Name
FLUIDSENSE FLUID DELIVERY SYSTEM
Manufacturer
Date Cleared
1998-11-30
(164 days)
Product Code
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
FLUIDSENSE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is intended for continuous or intermittent administration of fluid through clinically acceptable routes such as epidural, intravenous, irrigation, or subcutaneous pathways. The device is intended to control and monitor the flow of fluids, which may include:
1. Drugs and Electrolytes (e.g., cardiovascular drugs, antibiotics, analgesics, chemotherapy agents, TPN products, lipids, solutions for irrigation procedures, etc.)
2. Whole Blood and Blood Products.
The device is intended for use in:
1. Hospitals (e.g., burn / trauma units, cardiac catheter lab, critical / intensive care, delivery / post-partum, emergency room, general floor, labor / OR / anesthesia, medical / surgical, oncology, pediatrics / neonatal, post-anesthesia / recovery, etc.)
2. Outpatient / Surgical Centers
Device Description
The FluidSense Fluid Delivery System is intended for continuous or intermittent administration of fluid through clinically acceptable routes such as epidural, intravenous, irrigation, or subcutaneous pathways. It is a general purpose fluid delivery system which may be used for small and large volume delivery, PCA, and delivery from bag, bottle, or syringe. The system may be used to control and monitor flow of fluids such as:
- . Drugs and electrolytes ( e.g., cardiovascular drugs, antibiotics, anesthetics, analgesics, chemotherapy agents, TPN products, lipids, solutions for irrigation procedures, etc.)
- Whole blood and blood products .
The pump uses mechanical force (piston-driven diaphragm) to propel fluids through a narrow tube. The pump uses variable pressure, inertially dominated, volumetric metering to control flow. The pump includes means to detect fault conditions, such as air in, or the blockage of, the infusion line and to activate an alarm.
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