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510(k) Data Aggregation
K Number
K080105Device Name
ENDOTRACHEAL TUBE
Manufacturer
Date Cleared
2009-02-13
(396 days)
Product Code
Regulation Number
868.5730Why did this record match?
Applicant Name (Manufacturer) :
CHILECOM MEDICAL DEVICES CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Endotracheal tube is intented for oral or nasal intubation and for airway management.
Device Description
Tracheal Tube uncuffed (chart 1) and with cuffed (chart uncuffed of Tracheal Tube only make up of body and connector. Tracheal Tube with cuffed make up of body and connector、cuff、inflating tube、Pilot balloon、Valve。Tracheat tube with a radius of curvature.。 a line for x-radial through the body.。 All tubes have an angle of 38±10° . Length marks in centimeters measured from the patient end. The murphy eye on the side of the tube opposite the bevel. The tube machine end have the connector .It can connect the anesthesia machine or respiratory equipment. The inflating pilot balloon includes a valve fitting with a 6% (Luer) taper.
Each tracheal tube was contained in an individual pack . Sterilized by EOT. Single use only
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