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510(k) Data Aggregation
K Number
K240807Device Name
VM-2000
Manufacturer
Ventis Medical, Inc.
Date Cleared
2024-08-13
(141 days)
Product Code
CBK
Regulation Number
868.5895Why did this record match?
Applicant Name (Manufacturer) :
Ventis Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VM-2000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation in emergency and transport situations. The ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult patients, who require the following types of ventilatory support:
- Positive Pressure Ventilation, delivered invasively (via endotracheal tube or trach tube) or non-invasively (via mask).
- Assist/Control, SIMV, CPAP and NPPV modes of ventilation.
The ventilator is suitable for use in institutional or transport settings.
Device Description
The VM-2000 allows for rapid initiation of emergency ventilation based on default parameters. An operator can quickly begin ventilation by connecting the patient to the breathing circuit, and if necessary, adjusting ventilatory settings using the touch screen input before selecting start.
Once the therapy is initiated, breaths are delivered to the patient based on the configured settings. If the situation allows, qualified operators can adjust desired Mode, Tidal Vol, Respiratory Rate, PEEP, PIP, T Insp, P Insp and Sensitivity. Operators can monitor patients closely through a graphical breath-by-breath display to deliver highquality care. Audio and visual alarm indicators help troubleshoot issues.
The VM-2000 uses a single-patient-use breathing circuit with a Pressure Monitoring Line, and Flow Sensor to deliver air to patients using a motor-blower system. The unit has a Type BF Applied Part, which is the breathing circuit. The device can run on AC wall power and / or batteries. To support use in environments where compressed Oxygen is unavailable or ill-advised, the device does not require compressed Oxygen. The VM-2000 is compatible with low pressure oxygen sources and blenders but will function without supplemental FiO2.
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