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510(k) Data Aggregation
K Number
K983634Device Name
PREPARE HOME INFUSION PUMP
Manufacturer
Date Cleared
1999-02-24
(132 days)
Product Code
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL INFUSION TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Provide controlled, continuous, intravenous fluid therapy for ambulatory patients.
Device Description
An infusion pump used to pump fluids into a patient in a controlled manner.
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K Number
K970849Device Name
ENTERAL NUTRITION 1000 ML/500ML
Manufacturer
Date Cleared
1997-08-15
(161 days)
Product Code
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL INFUSION TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This product must be used only under a doctor's prescription. Its indications for use are medical situations wherein the patient is nourished by an appropriate formula by various means passed into the stomach from the nasal passage. It is used for patients means of a taoo passod into the steman and to masticate or swallow food. The product is not for intravenous feeding.
Device Description
The Enteral Nutrition device is equivalent to the RPI Enteral Feeding Bag, manufactured by Ridge Products, Inc., carrying 510(k) number K902641. The device is a common enteral feeding bag.
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