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510(k) Data Aggregation
K Number
K052389Device Name
I-PORT
Manufacturer
PATTON MEDICAL DEVICES
Date Cleared
2005-09-09
(9 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
PATTON MEDICAL DEVICES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The I-PORT™, Injection Port is indicated for patients who administer, or to whom is administered, multiple daily subcutaneous injections of physician prescribed medications, including insulin. The I-PORT™, Injection Port may remain in place for up to 72 hours to accommodate multiple drug injections without the discomfort of additional needle sticks. This device may be used on a wide range of patients, including adults and children.
Device Description
The 1-PORT™, Injection Port is a sterile, single use, low profile injection port through which physician prescribed medications can be injected subcutaneously from a standard syringe and needle, pen or alternative manual iniection device. The device is designed to reduce the hardships of multiple daily subcutaneous injections by allowing users to receive physician prescribed medication, including insulin, without repeated needle punctures of the skin. The I-PoRT™, Injection Port may remain in place for up to 72 hours to accommodate multiple drug injections without additional needle sticks.
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