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510(k) Data Aggregation
K Number
K170663Device Name
Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer
Manufacturer
Foremount Enterprise Co., Ltd.
Date Cleared
2018-05-11
(431 days)
Product Code
BTM, BYE, CAP
Regulation Number
868.5915Why did this record match?
Applicant Name (Manufacturer) :
Foremount Enterprise Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital care to temporary ventilate a patient for the given body mass ranges of: Infant: less than or equal to 10Kg. Child: less than or equal to 23 Kg. Adult: greater than 23 Kg
This manual resuscitator may be supplied with a single patient use positive end expiratory pressure (PEEP) valve and / or disposable Airway Pressure Manometer.
The PEEP Valve is a single patient use positive end expiratory pressure (PEEP) valve for use hospital. transport, emergency, and post hospital care to evaluate end lung pressure above atmospheric at the end of exhalation in constant and intermittent gas flow conditions. Intended for patients that the clinician has determined need PEEP.
The Disposable Manometer is a single patient use manometer intended to be used for monitoring the patient's airway pressure during ventilation. The manometer is to be used with resuscitation systems.
Device Description
Foremount Disposable PVC Resuscitators are portable medical devices used to temporarily augment ventilation in patients during ventilatory insufficiency or ventilatory failure. They consist of Ventilation Bag, Patient Valve, Intake Valves, Reservoir Bag, Oxygen Tubing, Cushion Mask, and optional Diverter Ring, PEEP Valve and Manometer. Foremount Disposable PVC Resuscitators come in three sizes along with a ventilation bag:
- . Infant - Less than or equal to 10 kg
- Child less than or equal to 23 kg ●
- Adult Greater than 23 kg. ●
The ventilation bags are available in three sizes based upon the intended patient population. They are provided with masks in three sizes (#1 - Infant, #3 - Child, and #5 - Adult). The patient valve includes a duck-bill valve to prevent rebreathing and incorporates a 40 cmH2O pop off valve for Child and Infant models. The patient valve includes a duck-bill valve to prevent rebreathing and incorporates a 60 cmH2O pop off valve for Adult models.
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