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510(k) Data Aggregation
K Number
K112915Device Name
SPIRTIUS CUFF INFLATION SYRINGE
Manufacturer
Date Cleared
2012-05-25
(235 days)
Product Code
Regulation Number
868.5750Why did this record match?
Applicant Name (Manufacturer) :
SPIRITUS TECHNOLOGIES LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SCIS will be used to inflate to 25±2 cmH2O the cuff of a high-volume, low-pressure endotracheal tube that has been intubated by a trained medical professional.
Device Description
The Spiritus Cuff Inflation Syringe (SCIS) is a disposable syringe that will initially inflate the cuff on an endotracheal tube (ETT) to a pressure of 79 cmH2O ± an average standard deviation of 9 cmH2O to create a proper seal with the patients trachea and then automatically decrease the pressure in the cuff to a final pressure of 25cm H2O ± an average standard deviation of 2 cmH2O. The SCIS is designed in the form of a syringe to reflect current practice of using a syringe to inflate the cuff. The device is made of medical grade ISO approved plastic material. The SCIS is intended as a single patient use disposable device.
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