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510(k) Data Aggregation
K Number
K152521Device Name
Seal Rite Non-Rebreathing Valve
Manufacturer
The Lifeguard Store, Inc.
Date Cleared
2016-06-03
(274 days)
Product Code
CBP
Regulation Number
868.5870Why did this record match?
Applicant Name (Manufacturer) :
The Lifeguard Store, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Seal Rite Non-Rebreathing Valve is a single-use, non-sterile device intended to be used with a ventilation mask (without oxygen port) to provide mouth-to-mask ventilation to health emergency victims requiring cardiopulmonary resuscitation ("CPR") rescue techniques. It is intended for over-the-counter use.
Device Description
The Seal Rite™ Non-Rebreathing Valve ("Seal Rite Valve") is a resuscitation valve designed for resuscitation using expired air for ventilation. It has fittings on the grooved patient end that will adapt to standard masks (22 mm ID) used for resuscitation. The Seal Rite Valve allows the rescuer to blow air into a mask through its silicone one-way valve and directs the patient's exhaled air away from the rescuer via a rigid one-way valve and multiple exhaust ports. The Seal Rite Valve helps protect the rescuer from potential patient contamination. The Seal Rite Valve does not have an oxygen port.
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