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510(k) Data Aggregation
K Number
K080527Device Name
TWINGUARD WITH CAPNOGRAPH ACCESSORY
Manufacturer
TRAWAX PTY LIMITED
Date Cleared
2008-10-31
(248 days)
Product Code
CCK, MNK
Regulation Number
868.1400Why did this record match?
Applicant Name (Manufacturer) :
TRAWAX PTY LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TwinGuard®, a nasal oxygen cannula and bite block, is used during endoscopy procedures to administer continuous oxygen to the nose and mouth. After endoscopy the bite block is removed, leaving the cannula in place during recovery, to continue delivering oxygen to the nose and mouth. In addition, the TwinGuard® contains an optional accessory which collects samples of the patient's breathing at the nose and mouth to measure CO2 with a capnograph during endoscopy procedures. It is intended for adult patients.
Device Description
The TwinGuard® consists of an endoscopic bite block with an oxygen nasal cannula, which are Class I devices, excmpt from premarket notification. The optional capnograph accessory, which enables continuous CO2 monitoring during cndoscopy procedures, is a Class II device.
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