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510(k) Data Aggregation
K Number
K141747Device Name
RHINOGUARD
Manufacturer
DAVIS MEDICAL
Date Cleared
2015-04-20
(294 days)
Product Code
BTR
Regulation Number
868.5730Why did this record match?
Applicant Name (Manufacturer) :
DAVIS MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Rhinoguard is a nasal endotracheal tube introducer/dilator designed to allow the passage of a nasal endotracheal tube from the nares to the oropharynx.
The device can be used with cuffed and non-cuffed nasal endotracheal tubes.
Device Description
The Rhinoguard is a nasal endotracheal tube introducer/dilator designed to ease the passage of a nasal endotracheal tube from the nares to the oropharynx. The Rhinoguard device is constructed primarily of polyvinylchloride and consists of a tube with a hollow proximal end, a tapered cylindrical body and a closed, rounded distal end. The device has markings to indicate the approximate mating location for corresponding sizes of nasal endotracheal tubes. The device is provided in a small and large size. The small Rhinoguard is intended to mate with 3.0 to 4.5 mm nasal endotracheal tubes and the large Rhinoguard is intended to mate with 5.0 to 8.0 mm nasal endotracheal tubes. The device can be used with cuffed and non-cuffed nasal endotracheal tubes. Prior to using the device, the desired size of the nasal endotracheal tube must be selected and then matched to corresponding Rhinoguard size (large or small). The device is then cut just above the indices (marks) corresponding to the selected endotracheal tube size and connected with the endotracheal tube. Once mated, the distal end of the device is introduced into the naris of choice and gently pushed forward into the oropharynx. Lastly, the distal end of Rhinoguard is grasped and removed from the mouth with the aid of a laryngoscope and McGill forceps.
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