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510(k) Data Aggregation
K Number
K243861Device Name
butterflyBVM
Manufacturer
Compact Medical, Inc.
Date Cleared
2025-04-25
(130 days)
Product Code
BTM
Regulation Number
868.5915Why did this record match?
Applicant Name (Manufacturer) :
Compact Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The butterflyBVM™ when used in transport and non-clinical emergency settings (e.g., EMS, non-hospital) is a single-use resuscitator that may be manipulated to provide pulmonary resuscitation of patients including adults, adolescents, children, infants, and neonates.
The butterflyBVM™ when used in professional healthcare facilities (e.g., hospitals) is a single-use resuscitator that may be manipulated to provide pulmonary resuscitation of patients including adults, adolescents, children, and infants.
Device Description
The butterflyBVM™ is a three-in-one bag-valve-mask capable of resuscitating adults, adolescents, children, infants, and neonates. The maximum tidal volumes (Vt) delivered by the butterflyBVM™ can be set via the tidal volume dial, as needed, to ranges that are generally appropriate for the size of patient receiving care. The butterflyBVM™ also has an adjustable peak inspiratory pressure (PIP) dial to help prevent barotrauma. The tidal volume and PIP are selected by aligning the dials to the Vt/PIP indicator. Patient-facing accessories such as masks, laryngeal mask airways, endotracheal tubes, end-tidal CO2 samplers, and the like can be connected to the patient connection port. Exhalation accessories such as bio filters and PEEP valves can be connected to the exhalation port. Supplemental oxygen can be added via the oxygen inlet port. The device is operated by manually squeezing the side arms together with either one or two hands. A cover is provided over the PIP dial to provide instruction to the user via images and words to first set the tidal volume for the procedure based on the assessment of the patient.
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