Search Results
Found 1 results
510(k) Data Aggregation
K Number
K093126Device Name
ANAPNOGUARD ENDOTRACHEAL TUBE
Manufacturer
HOSPITECH RESPIRATION LTD.
Date Cleared
2010-03-02
(151 days)
Product Code
BTP, BTR
Regulation Number
868.5420Why did this record match?
Product Code :
BTP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AnapnoGuard™ Endotracheal Tube is indicated for airway management by oral or nasal intubation of the trachea and for evacuation or drainage of the subglottic space.
Device Description
The AnapnoGuard™ Endotracheal Tube is a sterile, single-use device supplied with main lumen with a standard 15mm connector. Four lumens are embedded within tube walls. One is a standard lumen used for the inflation/deflation of the cuff. Two suction lumens are embedded in the dorsal side of the tube having spatially unified into one success above the cuff. The two suction lumens are unified into one external lumen. These lumens are used to evacuate secretions that accumulate above the cuff. A forth lumen is embedded on the ventral side of the tube having an inlet port above the cuff. It is used for a) venting the subglottis space during suction to avoid vacuum b) for saline (or other fluid) rinsing above the cuff to dilute the secretions and ease the suction c) for air sampling above the cuff to detect leakage of air from the lungs past the cuff. The AnapnoGuard ETT is comprised of the following components: Main lumen (PVC or Silicone), Cuff (Polyurethane for PVC tube and Silicone for Silicon tube), Cuff inflate/deflate lumen, Two suction lumens combined into one outside of the tube sealed with a cap, Venting/air and CO2 sampling lumen sealed with a cap, Murphy eye (with or without).
Ask a Question
Page 1 of 1