Non-invasive ventilation (NIV) is a kind of breathing support administered through a face mask, nasal mask, or a helmet. Air, usually with added oxygen, is given through the mask under positive pressure; generally the amount of pressure is alternated depending on whether someone is breathing in or out. Non-invasive ventilation is used in acute respiratory failure caused by a number of medical conditions.
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Product Model: Resmed S9, Lumis 150 VPAP ST
The VPAP ST is a bilevel device with backup rate that provides exceptional patient–ventilator synchrony, featuring Enhanced Easy-Breathe technology for quiet and comfortable therapy.
- Ultra quiet Easy-Breathe motor
- Intuitive menu settings and color LCD display
- Seamless integration with optional H5i™ heated humidifier with Climate Control
- Adjustable breath trigger/cycle
- Adjustable Rise Time
Please note: S9 VPAP ST is NOT listed on FDA Coronavirus Disease 2019 (COVID-19) emergency use authorizations (EUAs).
Product Model: YH725, YH730, YH830
Certification (accessible to the market): CE, FDA(EUA), CFDA
Featured Model Name: YH830, YH730, YH725
Type: Noninvasive ventilation (NIV)
Due to the short market supply, manufacturing capacity and bottleneck, please contact us for current ventilator products availability, specs, and pricing. Please note, price and availabilities change each day, consult our team for the most recent updates.
References: Additional FDA EUA announcements
FDA Policy for Modifications to FDA-Cleared Devices: FDA does not intend to object to limited modifications to the indications, claims, functionality, or to the hardware, software, or materials of FDA-cleared devices used to support patients with respiratory failure or respiratory insufficiency, without prior submission of a premarket notification under section 510(k) of the FD&C Act and 21 CFR 807.815 , for the duration of the declared public health emergency.
Modifications to FDA-Cleared Indications, Claims, or Functionality: For the duration of the public health emergency, to help foster the wider availability of devices for patients in need of ventilatory support, FDA does not intend to object to modifications to the FDA-cleared indications, claims, or functionality of these devices, without prior submission of a premarket notification where the modification will not create an undue risk in light of the public health emergency.
“I am waiving the following requirements for authorized ventilators, ventilator tubing connectors, and ventilator accessories during the duration of this EUA:
- Current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with respect to the design, manufacture, packaging, labeling, storage, and distribution of the authorized ventilators, ventilator tubing connectors, and ventilator accessories listed in Appendix B that are used in accordance with this EUA; and
- Registration and listing requirements, including the requirements under 21 CFR Part 807.”
*Additional information may be found at: Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, Guidance for Industry and Food and Drug Administration Staff, March 22 2020, URL: https://www.fda.gov/media/136318/download ; March 24, URL: https://www.fda.gov/media/136423/download
*FDA would find it helpful if such manufacturers (whether foreign or domestic) send FDA the following information to [email protected]; FDA believes this information will be valuable in assessing whether the device would be able to meet the EUA requirements.