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510(k) Data Aggregation
K Number
K090777Device Name
EZC MEDICAL, LLC INTUBAIDFLEX
Manufacturer
EZC MEDICAL, LLC
Date Cleared
2009-08-04
(134 days)
Product Code
BTR
Regulation Number
868.5730Why did this record match?
Applicant Name (Manufacturer) :
EZC MEDICAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IntubaidFlex" is intended for use as an aid in the placement of an Endotracheal Tube (ETT) directly or through an Intubating Laryngeal Mask Airway (LMA) during non difficult and difficult intubation procedures. The IntubaidFlex achieves its purpose by providing the user with a visual confirmation of where the tip of the device is in the human anatomy. The flexible tip of the IntubaidFlex allows the user to guide the ETT in the desired direction.
Device Description
The IntubaidFlex" is a simple, disposable, single-patient use, sterile, handheld, portable stylet with a built in camera, that fits within an Endotracheal tube (ETT) directly or through an Intubating Laryngeal Mask Airway(LMA) and provides for video-assisted visualization of the laryngeal inlet. The IntubaidFlex" can plug into any TV monitor, hand held monitor or PC (via USB) for live video visualization.
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