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510(k) Data Aggregation
K Number
K964920Device Name
RPI DUAL PORT IRRIGATION ADAPTER
Manufacturer
Date Cleared
1997-07-09
(212 days)
Product Code
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
RIDGE PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The use of this device is to gain additional access to an Enteral Gastrostomy Tube or Nasogastric Tube for the purpose of irrigation or the administration of medications without having to disconnect the Enteral Feeding Administration Set from the patients feeding tube.
The consistent connection or reconnection to a feeding tube each time a patient must be medicated or irrigated can not only cause patient discomfort, but also can cause the feeding tube to leak at the connection due to wear.
Device Description
RPI DUAL PORT IRRIGATION ADAPTER
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