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510(k) Data Aggregation
K Number
K102127Device Name
ENDOTRACHEAL TUBE CHANGERS
Manufacturer
INSTRUMENTATION INDUSTRIES, INC.
Date Cleared
2010-08-27
(29 days)
Product Code
LNZ
Regulation Number
868.5730Why did this record match?
Product Code :
LNZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters. JEM Series Endotracheal Tube Changers are intended for single patient use. This device is intended for sale by or on the order of a physician.
Device Description
The JEM Series Endotracheal Tube Changer consists of an extruded open lumen, imprinted with graduated markings. The graduated markings are used as a guide for the successful replacement of a tracheal tube.
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