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510(k) Data Aggregation
K Number
K050803Device Name
PEDIATRIC CUFFED AND UNCUFFED ET TUBES; STANDARD CUFFED AND UNCUFFED ET TUBES
Manufacturer
VITAID, LTD.
Date Cleared
2005-06-30
(92 days)
Product Code
BTR
Regulation Number
868.5730Why did this record match?
Applicant Name (Manufacturer) :
VITAID, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vitaid ET Tubes are designed for oral / nasal intubation and are indicated for airway management. The Vitaid ET tubes have an ultra thin inflatable cuff.
Device Description
The Vitaid endotracheal tubes are available in sizes 3.0 mm in increments of 0.5 mm. They are available cuffed, uncuffed and with Murphy eye. Some are pre-formed, they are made with a ultra thin urethane cuff, referred to as the MicroCuff.
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