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 In this section:

                COVID-19 Emergency Use Authorizations for Medical Devices

COVID-19 Emergency Use Authorizations for Medical Devices

                        Blood Purification Devices EUAs
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          In Vitro Diagnostics EUAs
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          Ventilators and Ventilator Accessories EUAs
          Other Medical Device EUAs Home
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          Medical Device Safety
          Emergency Situations (Medical Devices)
          Emergency Use Authorizations for Medical Devices
          COVID-19 Emergency Use Authorizations for Medical Devices
          Ventilators and Ventilator Accessories EUAsCOVID-19 Emergency Use Authorizations for Medical Devices Ventilators and Ventilator Accessories EUAs
  
  	
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    PrintNovember 8, 2023 - The COVID-19 public health emergency (PHE) declared under section 319 of the Public Health Service (PHS) Act expired on May 11, 2023. The COVID-19 enforcement policy guidances within scope of the *Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency* (see List 1) are no longer in effect.

The end of the COVID-19 PHE and certain COVID-19 enforcement policy guidances no longer being in effect do not impact the FDA's ability to authorize devices, including tests, for emergency use. Existing emergency use authorizations (EUAs) for devices relating to COVID-19 remain in effect under section 564 of the Federal Food, Drug, and Cosmetic Act. The FDA encourages manufacturers of devices issued EUAs related to COVID-19 to review the guidance: *Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)*, which outlines the FDA's recommendations and expectations to such manufacturers to transition to normal operations when the declarations that allowed for FDA to issue EUAs under section 564 of the Federal Food, Drug, and Cosmetic Act end. Additional information is provided on the page FAQs: What happens to EUAs when a public health emergency ends?


A continuous ventilator is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. FDA has issued EUAs to help increase the availability of ventilators and ventilator accessories, which are integral to treat patients with severe respiratory distress during the COVID-19 pandemic.

Umbrella EUA for Ventilators and Ventilator Accessories

On March 24, 2020, FDA issued an umbrella EUA in response to concerns about the insufficient supply and availability of FDA-cleared ventilators for use in health care settings to treat patients during the COVID-19 public health emergency. This EUA authorizes the emergency use of certain ventilators, anesthesia gas machines modified for use as ventilators, positive pressure breathing devices modified for use as ventilators, ventilator tubing connectors, and ventilator accessories that the FDA determines meet specified criteria for safety, performance, and labeling. See FAQs on Ventilators for more information.

The scope of this authorization is limited to the use of ventilators, ventilator tubing connectors, and ventilator accessories listed below in Appendix B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories for use in healthcare settings by patients during the COVID-19 public health emergency.

EUA Letter of Authorization - Ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators (collectively referred to as "ventilators"), ventilator tubing connectors, and ventilator accessories
	Facts Sheets for Healthcare Providers
	Facts Sheets for Patients
	Appendix A: Criteria for Safety, Performance and Labeling
	Appendix B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator AccessoriesFor Ventilator EUA: The interactive review template, which can be used to provide information to FDA, to support inclusion of an eligible product under the Ventilator EUA is available: Ventilator EUA Interactive Review Template (Updated April 21, 2020)

The tables below lists the ventilators, ventilator tubing connectors, and ventilator accessories authorized in this umbrella EUA.

Appendix B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories (Updated June 22, 2023)

The table below includes a list of authorized ventilator, ventilator tubing connector, and ventilator accessory to the list of authorized products in this Umbrella EUA during the COVID-19 public health emergency.

Authorized Ventilators
	Ventilators Removed from Appendix B
	Authorized Ventilator Tubing Connectors
	Ventilator Accessories Removed from Appendix B
	Authorized Ventilator AccessoriesAuthorized Ventilators

Date of Authorization
			Manufacturer
			Product Name
			Device Description
			Assigned Product Code
			Intended Use03/25/2020
			Beijing Aeonmed Co., Ltd
			VG70 ventilator
			Critical Care Ventilator
			QOV
			Mechanical ventilation of patients in ICU03/28/2020
			Shenzen Mindray Bio-medical Electronics
			Mindray SV300/SV600/SV800 ventilators
			Critical Care Ventilator
			QOV
			This product is intended to provide ventilation assistance and breathing support for adult,
			pediatric and infant patients03/28/2020
			Vyaire Medical, Inc.
			LTV2 model 2200 and LTV model 2150
			Critical Care Ventilator
			QOV
			LTV2 model 2200 and 2150 ventilators are intended to provide continuous or intermittent ventilatory support for the care of the individuals who require mechanical ventilation. The use environment is for institutional use. Institutional use includes ICU or other hospital environments including intra-hospital transport.Â The Model 2200 can operate with high O2.Â The Model 2150 operates with low pressure.03/30/2020
			RESMED
			Stellar 150 (Amended September 1, 2020)
			Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
			QOR
			The Stellar 150 is intended to provide ventilation for non-dependent, spontaneously breathing adult and pediatric patients (30 lb/13 kg and above) with respiratory insufficiency, or respiratory failure, with or without obstructive sleep apnea. The device is for noninvasive use, or invasive use (with the use of the ResMed Leak Valve).
			 
			The iVAPS mode with optional AutoEPAP is intended for patients weighing more than 66lb (30kg).
			Operation of the device includes both stationary, such as in hospital or home, or mobile, such as wheelchair usage.03/30/2020
			RESMED
			Lumis 150 VPAP ST (Amended April 17, 2020)
			Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
			QOR
			The ResMed Lumis 150 VPAP ST devices are indicated to provide non-invasive ventilation for patients weighing more than 30 lbs (13 kg), or more than 66 lbs (30kg) in iVAPS mode, with respiratory insufficiency or obstructive sleep apnea (OSA). They are intended for home and hospital use. The ResMed Lumis 150 VPAP ST devices can be used with an attachable humidifier that is intended for single patient use in the home environment and re-use in a hospital/institutional environment.03/31/2020
			RESMED
			GA ST
			Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
			QOR
			The GA non-invasive ventilator is an assist ventilator and is intended to augment patient breathing. It is intended solely for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician. The ventilator is intended to support patients weighing 20 kg (44 lb) or greater. The ventilator is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists.03/31/2020
			RESMED
			Flexo Bi-Level ST
			Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
			QOR
			Flexo Bi-level positive airway pressure therapy device is used to provide nonâ€invasive ventilatory support of mechanical ventilation for: Patients who are independent and spontaneously breathing, Patients with respiratory insufficiency and sleeping breathing disorders. It can provide both a stable continuous positive airway pressure and a biâ€level positive airway pressure. It is not a life support ventilator. It is intended to be used in the home or professional medical environment. The therapeutic pressure is prescribed by a physician according to patients' condition.03/31/2020
			RESMED
			AirCurve S T  (Amended
			April 17, 2020)
			Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
			QOR
			AirCurve ST device has indications for use that include respiratory insufficiency. The AirCurve ST device is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (30kg). It is intended for home and hospital use.03/31/2020
			Amsino
			YUWELLÂ®
			YH-730 Bi-level PAP and YH-830 Bi-level PAP
			Ventilator, Non-Continuous
			QOQ
			The Bi-level device is indicated for treatment of sleep apnea hypopnea syndrome in patients weighing more than 66lb (30kg). It is intended both for home use and hospital use. The water tank is intended for single patient use in the home environment and re-use in a hospital/institutional environment.03/31/2020
			Inovytec
			Ventway Sparrow
			Ventilator, Continuous
			QOS
			The Ventway Sparrow ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 5 kg (11 lb), who require the following types of ventilatory support: SIMV - VC (PS), CPAP. The Ventway Sparrow lung ventilator is intended for emergency use and during transportation. It may be used for invasive or non-invasive ventilation presets. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician.04/01/2020
			Philips Respironics
			VX850 Ventilator
			Critical Care Ventilator
			QOV
			The VX850 ventilator is intended to provide continuous or intermittent respiratory support and monitoring of pediatric and adult patients. The VX850 is intended to be used in a hospital or other institutional healthcare environment and is intended for intra-facility transport. The VX850 ventilator is intended for use by qualified, trained personnel under direction of a physician. The VX850 is intended for use with pediatric (infants) ages 2 months to 2 years and weighing 5 kg or greater, up to and including adult patients.04/02/2020
			BMC Medical CO., LTD
			Luna G3 BPAP 25A- LG3700
			Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
			QOR
			The G3 B25A BPAP System is a Bi-level PAP (Bi-level Positive Airway Pressure) device, which is intended to provide non-invasive ventilation for patients with Obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. These devices are intended for adult patients by prescription in the home or hospital/institutional environment.04/02/2020
			BMC Medical Co., Ltd.
			Y-30T
			Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
			QOR
			BPAP System (Y-30T Model) is a Bi-level PAP (Bi-level Positive Airway Pressure) device, which is intended to provide non-invasive ventilation for patients with obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. Y-30T device is intended for adult patient by prescription in the home or hospital/institutional environment. This device is not intended for life support. The optional Heated Humidifier used with the Y-30T device together is indicated for taking humidifying and heating air from the device.04/02/2020
			Dragerwerk AG & CO. KGaA
			Evita V800 and Evita V600
			Critical Care Ventilator
			QOV
			The intensive care Ventilator Evita is intended for the Ventilation of adults, adolescents, children, infants and neonates. This device provides mandatory Ventilation modes and Ventilation modes for supporting spontaneous breathing as well as Ventilation monitoring04/03/2020
			Dragerwerk AG & CO. KGaA
			Babylog VN800 and VN600
			Critical Care Ventilator
			QOV
			The intensive care ventilator Babylog is intended for the ventilation of neonates from 0.4 kg (0.88 lb) up to 10 kg (22 lb), and pediatric patients from 5 kg (11 lb) up to 20 kg (44lb) bodyweight. This device provides mandatory ventilation modes and ventilation modes for supporting spontaneous breathing as well as ventilation monitoring.04/05/2020
			Covidien LLC
			Puritan Bennett 560 Ventilator System
			Ventilator, Continuous,
			QOS
			The Puritan Bennett 560 Ventilator is indicated for the continuous or intermittent mechanical ventilatory support of patients weighing at least 11 lb (5 kg) who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a doctor. It is essential to read, understand, and follow these instructions before using the Puritan Bennett 560 Ventilator. Specifically, the ventilator is applicable for adult and pediatric patients who require the following general types of invasive or non-invasive ventilatory support, as prescribed by an attending doctor:

			Positive Pressure ventilation
				Assist/Control, SIMV, or CPAP modes of ventilation
				Breath types including Volume Control, Pressure Control, and Pressure Support The ventilator is suitable for use in institutional, home, and portable settings. It is not intended for use in Emergency Medical Service (EMS) such as an emergency transport.04/06/2020
			CoLabs
			COVID Ventor
			Emergency Ventilator
			QOT
			The COVID Ventor system is an emergency use ventilator used to provide adult patients with emergency ventilatory support when no alternative FDA-approved ventilators are available.Â The COVID Ventor System consists of the reusable Ventor Console (Console) and the single use, disposable Ventor-Specific Breathing Circuit (Breathing Circuit).Â The COVID Ventor is able to provide Pressure Controlled, Pressure Supported, and Volume Controlled long-term ventilatory support in emergency situations04/06/2020
			MEKICS Co,. Ltd
			MTV1000 ventilator
			Ventilator, Continuous
			QOS
			MTV1000 ventilator is designed for use on patient population sizes from pediatric through adult who require respiratory support or mechanical ventilation and weigh a minimum of 5.0 kg. It is suitable for service in hospitals to provide continuous positive pressure ventilatory support using medical oxygen and compressed medical air from internal air sources to deliver oxygen concentrations of 21 % to 100 %. Ventilatory support can be delivered invasively or noninvasive.04/07/2020
			DrÃ¤gerwerk AG & Co. KGaA
			Atlan A350 and Atlan A350 XL
			Gas-Machine, Anesthesia
			QOT
			This device is intended for use in anesthetizing adults, pediatric patients, and neonates. The device can be used for mechanical ventilation, manual ventilation,
			pressure-supported spontaneous breathing, and spontaneous breathing. The device is equipped with the following basic functions:

			Ventilation monitoring
				Inspiratory O2 measurement
				Device monitoring
				Anesthetic gas receiving systemThe following options are additionally available:

			Patient-gas measurement module for O2, CO2, N2O, and anesthetic gases
				O2 insufflationAnesthesia is achieved through a mixture of pure oxygen and Air (medical compressed air) or pure oxygen and nitrous oxide, with the addition of volatile
			anesthetic agents. Ventilation is accomplished on the patient through a laryngeal mask, a breathing mask, or an endotracheal tube. The integrated breathing system can be used with partial rebreathing (low-flow or minimum-flow).04/07/2020
			VenTec Life Systems
			V+Pro Emergency Ventilator
			Ventilator, Continuous
			QOS
			VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. It may be used in invasive and non-invasive applications. VOCSN is intended for pediatric through adult patients weighing at least 5 kg. It is intended for use in home, hospital, institutional, and transport settings, including portable applications.04/08/2020
			AMBULANC TECH.CO.,LTD
			Models 6000S, T5, T7
			Emergency Transport Ventilator
			QOT
			Model 6000S - The 6000S ventilator is intended to provide continuous ventilation for patients who require invasive or noninvasive respiratory support and weigh more than 15KG (Infants, children, adults). The 6000S ventilator offers IPPV (Intermittent Positive Pressure Ventilation Mode), AC (Assisted Control Ventilation Mode), CPR auxiliary modes, etc. The 6000S ventilator can display the monitoring pressure waveform and interface parameters (Pmax, Pmean) in real time. The 6000S Ventilator is intended for use in emergency treatment outside the hospital and in-hospital transportation, and it runs under the central oxygen supply of the hospital or an oxygen cylinder pressure greater than 2.7Bar.

			Model T5 - The T5 ventilator is intended to provide continuous ventilation for patients who require invasive or noninvasive respiratory support (Infants, children, adults), with a tidal volume greater than 50ml. The T5 ventilator offers capacity control (IPPV, VAC, VSIMV), pressure control (PCV, PAC, PSIMV), noninvasive breathing (CPAP) modes, etc. It also has CPR auxiliary function and ETCO2 detection function. The T5 ventilator can display pressure waveform, ETCO2 waveform and parameters (pressure, tidal volume, ETCO2) in real time. The T5 ventilator is intended for use in out-of-hospital emergency treatment (first aid treatment on the ground, at sea, and in the air) and in-hospital transportation run under the central oxygen supply of the hospital or an oxygen cylinder pressure greater than 2.7Bar. Model T7 - The T7 ventilator is intended to provide continuous ventilation for patients with weight greater than 2kg (infants, children, adults) who require invasive or noninvasive respiratory support, with a tidal volume greater than 20ml. The T7 ventilator offers volume control (IPPV, VAC, VSIMV), pressure control (PCV, PAC, PSIMV), non-invasive (CPAP, CPAP + PSV, BiPPV, APRV), advanced ventilation (PRVC, PRVC + PSV, APRV + PSV), resuscitation mode (CPR, RSA, HFNC), etc.; and has functions such as ETCO2, ring chart, respiratory mechanics and trend chart. The T7 ventilator can display pressure waveform, flow waveform, tidal volume waveform, ETCO2 waveform and interface parameters (pressure, tidal volume, ETCO2, FIO2) in real time. The T5 ventilator is intended for use in out-of-hospital emergency treatment (first aid treatment on the ground, at sea, and in the air) and in-hospital transportation run under the central oxygen supply of the hospital or an oxygen cylinder pressure greater than 2.7Bar.04/08/2020
			Philips Respironics
			E30 ventilator
			Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
			QOR
			The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It is specifically for the care of adult and pediatric patients >7 years of age and >18kgs. It is intended to be used in the hospital or other institutional healthcare environments, as well as spaces converted for the care of large numbers of COVID-19 patients (e.g. convention centers, university dormitories, motels). The Philips Respironics E30 ventilator is intended for use by qualified, trained personnel under the direction of a physician.04/08/2020
			Incoba LLC
			Apogee
			Oxygen Conserver
			QOQ
			The Apogee gas conserver is intended as a delivery device for medical grade oxygen from high-pressure oxygen cylinders. This is an ambulatory device which allows patients to ambulate longer than they would with a continuous flow regulator on the same cylinder. The Apogee is intended to be used in the hospital, healthcare facilities, or home care environments.

			The Apogee Device shall be used by trained professionals either in a doctor's office or clinical setting initially. However, once recommended by the physician or healthcare provider the device can be prescribed for use within a home environment for subsequent treatments.

			The Apogee Device essential performance is to provide short puffs of air during operation as noted on the display for nasal output L or R. In the event air is not delivered use the bypass adaptor and return the device to Dynaris for immediate replacement.

			The Apogee unit is a regulated device and carries warnings and cautions regarding safe use of this product. Failure to read this manual and adhere to the warnings and caution stated within the manual can affect device performance and potentially harm to the user.

			The Apogee Device and its accessories do not contain any natural rubber latex-containing components.04/13/2020
			SecondBreath LLC
			Pneumatic Resuscitator device
			Emergency Resuscitator
			QOU
			The SecondBreath LLC Pneumatic Resuscitator is an electric pneumatic ventilator. This system uses compressed air to drive a pneumatic cylinder equipped with a plunger to compress an AMBU bag and provides the patient with positive inspiratory pressure. This device is intended only for use for transport or emergency resuscitation unless there are no other ventilation modalities available due to emergency resource limitations. The user can set tidal volume (TV), inspiratory to expiratory (I:E) ratio, respiratory rate, expiratory pause, and inspired oxygen (FiO2) at a constant 1.0 rate. Pure oxygen can be delivered through the AMBU bag. The device can only be operated in volume control (VC) continuous mandatory ventilation mode. Continuous end-tidal carbon dioxide monitoring is required for safe use of this device since there are no alarms for TV not met/exceeded. Additionally, power supply needs to be monitored as there is a loss of power alarm but no backup power supply to provide ventilation.04/14/2020
			University of Minnesota Medical School and Boston Scientific Corporation
			Coventor Adult Manual Resuscitator Compressor
			Emergency Resuscitator
			QOU
			This device is intended for compression of an adult manual resuscitator device intended for pulmonary resuscitation of adult patients for whom no other appropriate means of mechanical ventilation exists due to resource limitations from pandemic conditions in the region of use.04/14/2020
			Umbulizer
			UMV-001 EUA
			Emergency Resuscitator
			QOU
			The Umbulizer UMV-001 is intended to provide ventilatory support to adults when Positive Pressure Ventilation (PPV) is required to manage Acute Respiratory Failure (ARF). The Umbulizer series is appropriate for adults that weigh at least 45 kg (approximately 99 lbs). It is intended to be used in a pre-hospital, field hospital, and transport environments, as well as hospital settings where sufficient standard ventilators are not available.04/16/2020
			Hillrom
			MetaNeb 4
			Intermittent Positive Pressure Breathing Device
			QOQ
			The MetaNeb 4 System is indicated for mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and also has the ability to provide supplemental oxygen when used with compressed oxygen. Patient Population â€" 5 years old and above whom can follow verbal instructions. Environment of Use â€" Hospitals, sub-acute and nursing facilities, physician offices, clinics, and home settings.04/17/2020
			Spiro Devices LLC
			Spiro Wave (Amended June 8, 2020)
			Emergency Resuscitator
			QOU
			The Spiro Wave is an automated manual resuscitator that has been designed specifically to meet AAMI guidelines for emergency use resuscitators and provide respiratory support for adult patients in acute respiratory failure. It does not replace standard mechanical ventilation but acts as a bridge to standard mechanical ventilation by increasing the functionality of existing manual resuscitator bags. The Spiro Wave is compatible with existing manual resuscitator bags, and clinicians can control key ventilatory parameters. The Spiro Wave is designed to provide basic ventilator functionality to a single adult patient, in an emergency situation when there are no other options available to the patient.04/17/2020
			RESMED
			AirCurve 10 ST-A
			Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
			QOR
			The AirCurve 10 ST-A is indicated to provide noninvasive ventilation for patients weighing more than 30lbs (13 kg) with respiratory insufficiency or obstructive sleep apnea (OSA). The iVAPS mode is indicated for patients weighing more than 66lbs (30 kg). The AirCurve 10 ST-A is intended for home and hospital use. The humidifier is intended for single patient use in the home environment and re-use in a hospital/institutional environment.04/17/2020
			PVA
			PREVENT
			Emergency Resuscitator
			QOU
			PREVENT is indicated for emergency resuscitation with appropriate critical care monitoring on adult patients weighing at least 66 pounds that require mechanical respiratory support where standard ventilators are not available during the National Emergency.04/20/2020
			3B Medical Inc
			Luna G3 B30VT
			Ventilator, Continuous, Minimal Ventilatory Support
			QOR
			The G3 B30VT BPAP is a Bi-level PAP (Bi-level Positive Airway Pressure) device, which is intended to provide non-invasive ventilation for patients with Obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. These devices are intended for adult patients by prescription in the home or hospital/institutional environment.04/20/2020
			Resvent
			iBreeze PAP
			Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
			QOR
			The iBreeze PAP system delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea (OSA) in spontaneously breathing patients weighting over 30kg (66lbs) for use in the home, hospital, or institutional environment.04/22/2020
			Virgin Orbit
			Virgin Orbit Resuscitator (Amended
			April 23, 2020)
			Emergency Resuscitator
			QOU
			This emergency use resuscitator is for use with appropriate critical care monitoring on adults (>18 years of age) requiring mechanical ventilation during declaration of National Emergency where ventilator need has surpassed ventilator supply and no other ventilatory support devices are available.04/23/2020
			Amsino International Inc's
			YUWELL YH-725 BiPAP
			Ventilator, Non-Continuous
			QOQ
			The YH-725 Bi-level device is indicated for treatment of sleep apnea hypopnea syndrome in patients weighing more than 66lb (30kg). It is intended both for home use and hospital use. The humidifier is intended for single patient use in the home environment and re-use in a hospital/institutional environment.04/24/2020
			AutoMedX Inc.
			SAVe II Series Ventilator
			Powered Emergency Ventilator
			QOT
			The SAVe II series are intended to provide ventilatory support for adults during CPR or when Positive-Pressure Ventilation (PPV) is required to manage Acute Respiratory Failure (ARF) or other situations where mechanical ventilation is needed. The SAVe II series are appropriate for adults that weigh at least 45 kg. It is intended to be used in pre-hospital, field hospitals, outpatient environments, hospitals, ICU's, transport environments or any other healthcare environment requiring the use of ventilator.04/24/2020
			SLS Medical Technology Corp. Ltd.
			CP101/CP101S Series
			Ventilator, Non-Continuous
			QOQ
			This CPAP (Continuous Positive Airway Pressure) product can provide a continuous and positive airway in patients with respiratory insufficiency. This product provides 4~20 cmH2O of positive airway pressure and is equipped Oxygen Inlet to allow multiple Oxygen sources i.e. Oxygen generator. It is intended to be used under prescription of a physician.04/24/2020
			Zhejiang LifeMed Technology Co., Ltd.
			LA Series Ventilators LA20C, LA20A, LA20B, LA20B, LA25B, LA25B
			Ventilator, Non-Continuous
			QOQ
			The LifeMed LA Series Ventilator is a ventilator indicated for the treatment of respiratory insufficiency in patients weighing more than 30kg (66 lbs). It is intended for hospital use. The built-in humidifier is intended for repeated use by the same patient.04/27/2020
			Resvent Medical Technology CO., Ltd's
			iBreeze 30STA device
			Ventilator, Non-Continuous
			QOQ
			The iBreeze 30STA PAP system delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea (OSA) in spontaneously breathing patients weighing over 30kg (66lbs), it is for use in the home, hospital, or institutional environment.04/28/2020
			Shenzhen Yamind Medical Tech
			CPAP Devices: DM28-20C-G;
			Auto CPAP Devices: DM28-20A-W, DM28-20A-WP;
			BiPAP Devices: DM28-20S-G, DM28-20SA-G, DM28-20ST-G, DM28-25S-B, DM28- 25SA-BP, DM28-25ST-BP, DM28-30ST-B, DM28-30ST-BP, DM28-30STA-BP
			Ventilator, Non-Continuous
			QOQ
			The subject device provides noninvasive ventilation for patients with obstructive sleep apnea. It is indicated for adult patients weighing more than 30kg and can be used in homes and hospitals. It is not intended for life support, or for central sleep apnea. It may be used to improve the oxygenation and ventilation in the treatment of acute respiratory illness or difficulty breathing.04/30/2020
			NASA Jet Propulsion Laboratory
			VITAL ventilator
			Emergency Ventilator
			QOT
			The VITAL ventilator is intended to provide continuous ventilatory support for adult (body weight ≥ 50 kg) patients who require mechanical ventilation. VITAL provides patients with emergency ventilatory support when no alternative standard ventilators are available. The VITAL ventilator is a restricted medical device intended for use by qualified healthcare provider who understands the functionality of the device operating under the direction of a physician.04/30/2020
			Venti-Now
			Venti-Now Resuscitator
			Model JM-P2020A
			Emergency Resuscitator
			QOU
			The Venti-Now resuscitator is indicated for continuous or intermediate mechanical support of adult patients who require mechanical ventilation. The resuscitator is a restricted medical device intended for use by qualified, trained personnel under the direction of a Physician for COVID-19/Emergency use when no FDA-cleared ventilators are available. It is essential to read, understand, and follow these instructions before using the Venti-Now resuscitator. The Venti-Now resuscitator is a volumetric device that compresses a disposable BVM bag to create the positive pressure airflow to the patient. As such its use is applicable for use where a BVM unit is in use today. In addition, the unit has means to control Tidal volume, Inhalation/Exhalation rates, and bpm that make it suitable for a broader range of target patients than manually pumped BVM bags.05/01/2020
			Elemaster S.p.A. Tecnologie Elettroniche
			Mechanical Ventilator Milano (MVM)
			Emergency Ventilator
			QOT
			The MVM is a pressure-regulated mechanical ventilator designed for adult patients to provide emergency ventilatory support when no alternative standard ventilators are available.

			The device should be used by:

			healthcare professionals responsible for the treatment of a patient on ventilation support equipment, and
				staff who will be performing routine maintenance on the device. The MVM is intended to provide ventilation support for intensive therapy during the COVID-19 pandemic for patients who require mechanical ventilation and weigh more than 40 kg (88 lbs).05/02/2020
			BMC Medical CO., LTD., China
			Luna G3 BPAP S/T- LG3800-G3 B30VT
			Ventilator, Continuous, Minimal Ventilatory Support
			QOR
			The G3 B30VT BPAP is a Bi-level PAP (Bi-level Positive Airway Pressure) device, which is intended to provide non-invasive ventilation for patients with Obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. These devices are intended for adult patients by prescription in the home or hospital/institutional environment.05/02/2020
			ZIBO ZHONGXUN MEDICAL EQUIPMENT CO. LTD
			ZXH-550
			Emergency Ventilator
			QOT
			The ventilator is intended to provide continuous ventilatory support for adult patients who require mechanical ventilation. The ventilator is a restricted medical device intended for use in hospitals and hospital-type facilities, which provide respiratory care for patients requiring respiratory support.05/02/2020
			JIUXIN MEDICAL
			JIXI H-100
			Emergency Ventilator
			QOT
			The ventilator is intended to provide continuous ventilatory support for adult patients who require mechanical ventilation. The ventilator is a restricted medical device intended for use in hospitals and hospital-type facilities, which provide respiratory care for patients requiring respiratory support.05/05/2020
			Vayu Global Health Innovations
			Vayu bubble Continuous Positive Airway Pressure Circuit ("Vayu bCPAP')
			Continuous Positive Airway Pressure Circuit
			QOQ
			The Vayu bCPAP system is intended to provide continuous positive airway pressure in the hospital environment to spontaneously breathing neonates and infants, up to 5 kg in weight, that require respiratory support due to conditions associated with prematurity, such as Respiratory Distress Syndrome, or other conditions where the physician desires and prescribes CPAP.05/06/2020
			Hunan Beyond Medical Technology Co., Ltd
			BEYOND C20A CPAP
			Ventilator, Continuous, Minimal Ventilatory Support
			QOR
			The C20A CPAP is designed for delivery of positive airway pressure to provide non-invasive ventilation for adult patients with respiratory insufficiency or obstructive sleep apnea (OSA) in home or hospital environment.05/06/2020
			Hunan Beyond Medical Technology Co., Ltd
			BEYOND B30P BiPAP
			Ventilator, Continuous, Minimal Ventilatory Support
			QOR
			The B-30P BiPAP is designed for delivery of positive airway pressure to provide non-invasive ventilation for adult patients with respiratory insufficiency or obstructive sleep apnea (OSA) in home or hospital environment. The device is to be used only under the prescription of a licensed health care professional.05/06/2020
			Guangzhou Hypnus Healthcare Co., Ltd.
			Hypnus ST730
			Ventilator, Continuous, Minimal Ventilatory Support
			QOR
			The device is indicated to provide non-invasive positive airway pressure to spontaneously breathing patients weighing over 30kg with Obstructive Sleep Apnea (OSA) or respiratory insufficiency. This device is intended for hospital and home use. It is not intended for patients dependent on mechanical ventilation.05/07/2020
			AutoMedX, Inc.
			SAVe II+ (M50016, M50017)
			Powered Emergency Ventilator
			QOT
			The SAVe II series are intended to provide ventilatory support for adults during CPR or when Positive-Pressure Ventilation (PPV) is required to manage Acute Respiratory Failure (ARF) or other situations where mechanical ventilation is needed. The SAVe II series are appropriate for adults that weigh at least 45 kg. It is intended to be used in pre-hospital, field hospitals, outpatient environments, hospitals, ICU's, transport environments or any other healthcare environment requiring the use of a ventilator.05/08/2020
			Taiyuan Shanghai Medical
			Fabius Plus / Fabius Plus XL
			Gas Machine, Anesthesia
			QOT
			Fabius plus is an inhalation anesthesia workstationfor use in operating, induction and recovery rooms.It may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders.Fabius plus is equipped with a compact breathing system, providing fresh-gas decoupling, PEEP, and pressure limitation. The following ventilation options are available: –Volume Controlled Ventilation -Pressure Controlled Ventilation (Optional) –Pressure Support (Optional) –SIMV/PS (Optional) –Manual Ventilation –Spontaneous Breathing. Fabius plus is equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratoryoxygen concentration (Fi02).05/08/2020
			Somnetics International, Inc.
			Transcend 3 BiPAP
			Ventilator, Non-Continuous
			QOQ
			The Transcend 3 BiPAP is intended for the therapy of adults weighing over 66 pounds (30 kg) with mild to moderate respiratory distress. The device delivers positive airway pressure (PAP), specifically positive end-expiratory pressure (PEEP) with ventilatory support, to provide ventilation assistance and breathing support. The device is intended for use in healthcare settings.05/12/2020
			Lanick Med Systems LLC
			Lyra x1 and Lyra x2 Ventilators
			Ventilator, Continuous, Facility Use
			QOS
			The LYRA xl ventilator is a mechanical ventilator designed to provide invasive and noninvasive, continuous or intermittent. respiratory support for pediatric and adult patients.

			Intended areas of use:

			In the intensive care ward or in the recovery room.
				During transfer of-ventilated patients within the hospital. The LYRA xl ventilator is intended for use by qualified. trained personnel under the direction of a physician and within the limits of its stated technical specifications.The LYRA x2 ventilator is a mechanical ventilator designed to provide invasive and noninvasive, continuous or intermittent, respiratory support for pediatric and adult patients. Intended areas of use:

			In the intensive care ward or in the recove1y room
				During transfer of ventilated patients within the hospital. The LYRA x2 ventilator is intended for use by qualified, trained personnel under the direction of a of a physician and within the limits of its stated technical specifications. May 12,05/15/2020
			CMI Health
			Beijing Aeonmed Shangrila510S
			Emergency Transport Ventilator
			QOT
			The Shangrila510S is an emergency transport ventilator intended to be used to provide ventilatory support in the emergency rooms of hospitals, transfer after operations, field and occasions where first aid or transfer is needed for care of adult ,pediatric patients weighting at least 3.5 kg who require mechanical ventilation.05/18/2020
			SysMed (China) Co., Ltd
			VM series- DPAP20 Plus, DPAP25 Plus, DPAP25 Pro, DPAP30 Pro
			Ventilator, Continuous, Minimal Ventilatory Support
			QOR
			The device delivers positive pressure therapy for the treatment of Obstructive Sleep Apnea or respiratory insufficiency in spontaneously breathing adults weighing over 30kg (66 lbs). It is for use in the home or hospital/institutional environment.05/20/2020
			SysMed (China) Co., Ltd
			Resware BI 20 S, Resware BI Auto S, Resware BI 25 S/T, Resware BI 30 S/T, ZiZ Auto, Aurora Bi-Level S, Aurora Bi-Level S/T, Aurora Bi-Level Auto S
			Ventilator, Continuous, Minimal Ventilatory Support
			QOR
			The Resware, ZiZmer, and Aurora CPAP products provide positive pressure therapy for the treatment of obstructive sleep apnea or respiratory insufficiency in spontaneously breathing adults weighing over 30 kg (66 lbs). This product can be used in the home as well as in clinical/hospital environments.05/22/2020
			Guangzhou Hypnus Healthcare Co., Ltd
			BA825W, BA825, ST830W and ST830
			Ventilator, Continuous, Minimal Ventilatory Support
			QOR
			Hypnus Positive Airway Pressure Device 8 Series are indicated to provide non-invasive positive airway pressure to spontaneously breathing patients weighing over 30kg with Obstructive Sleep Apnea (OSA), and BPAP-T mode and BPAP-ST mode can be used for respiratory insufficiency. This device is intended for hospital and home use. It is not intended for patients dependent on mechanical ventilation.05/22/2020
			Origin Medical Devices Inc.
			Panther 5 Model P5DLVENT
			Ventilator, Continuous, Facility Use
			QOS
			The PANTHER 5 ventilator is intended to provide continuous ventilation to adult patients requiring respiratory support. The device is intended for facility use under clinical supervision.06/01/2020
			NASA Jet Propulsion Laboratory
			VITAL Compressor
			Emergency Ventilator
			QOT
			The VITAL Compressor ventilator is intended to provide continuous ventilatory support for adult (body weight ≥ 50 kg) patients who require mechanical ventilation. VITAL provides patients with emergency ventilatory support when no alternative standard ventilators are available. The VITAL Compressor ventilator is a restricted medical device intended for use by qualified healthcare provider who understands the functionality of the device operating under the direction of a physician.06/01/2020
			Fitbit, Inventec Appliances Corp (Authorized Distributor)
			Fitbit Flow (Amended October 8, 2020)
			Emergency Resuscitator
			QOU
			The Fitbit Flow is indicated for the continuous mechanical ventilatory support of adult patients. The Fitbit Flow is an accessory to a manual resuscitator and consists of a reusable mechanical actuator and the single-use, disposable tubing assembly. The Fitbit Flow supports conventional Volume Control and Pressure Control modes of ventilation, as well as an "Assist Control" feature to support breaths triggered by the patient. The Fitbit Flow is intended for use by qualified, trained personnel under the direction of a physician only when an FDA-cleared clinical ventilator is not available during the COVID-19 pandemic.06/08/2020
			BioMedInnovations, LLC
			SuppleVent
			Emergency Ventilator
			QOT
			The SuppleVent Ventilator is an Emergency Use Ventilator (EUV) indicated to provide continuous ventilatory support of adult patients who require mechanical ventilation when an FDA cleared ventilator is not available due to COVID-19 pandemic. The ventilator is intended for institutional use by qualified, trained personnel under the direction of a doctor. Institutional use includes Intensive Care Unit (ICU) or other hospital environments including intra-hospital transport and temporary hospital facilities.06/09/2020
			Nanotronics Imaging, Inc
			nHale BiPAP device
			Ventilator, Continuous, Minimal Ventilatory Support
			QOR
			The nHaleTM is a bi-level positive air pressure (BIPAP) device to support respiratory therapy of spontaneously breathing adults weighing over 30kg suffering from COVID-19 disease in traditional healthcare facilities (e.g., hospitals, assisted living facilities, nursing homes) as well as spaces converted for the care of large numbers of COVID-19 patients (e.g., convention centers, university dormitories, motels, etc.). The nHaleTM is a non-invasive ventilator designed to be used in non-life-threatening situations, for spontaneously breathing patients, where a patient is in need of breathing assistance but is not in need of invasive ventilatory support based on standard medical protocols.06/10/2020
			Enexor BioEnergy, LLC
			X-VENT Emergency Ventilator
			Emergency Ventilator
			QOT
			The X-VENT is a continuous use, emergency ventilator intended to provide invasive and non-invasive ventilatory support for adult patients > 35 kg of weight with respiratory insufficiency or failure. The X-VENT is to be used under prescription only and is intended to be used in hospitals, hospital-type facilities, or other institutional health care environments. X-VENT provides patients with emergency ventilatory support when no alternative standard ventilators are available.

			The X-VENT is intended for use by qualified physicians and respiratory therapists who have undergone training on the use of the X-VENT ventilator. It provides three (3) modes of ventilation: pressure control, volume control, and assist control (volume and pressure).06/17/2020
			NeoNatal Rescue, LLC
			AdultLife Pro Ventilator
			Emergency Ventilator
			QOT
			The AdultLife Pro Ventilator is intended for emergency ventilatory care of hospitalized adult patients greater than 35kg in weight who are experiencing respiratory insufficiency or respiratory failure. The unit is designed to be used at the bedside in hospital environments, from an intensive care unit to other facilities, for use by trained professionals in respiratory care. Patients can be treated with the AdultLife Pro Ventilator for as long as their symptoms persist.  AdultLife Pro Ventilator provides patients with emergency ventilatory support when no alternative standard ventilators are available.06/19/2020
			World Ventilator Foundation (WVF)
			WorldVent Ventilator
			Emergency Ventilator
			QOT
			The World Ventilator Foundation (WVF) WorldVent is intended to provide continuous ventilation for adult patients who require invasive respiratory support. It provides Volume Controlled Ventilation (VCV) mode provided in both mandatory and spontaneous assist control fashions as well as respiratory monitoring.
			The WorldVent is intended for use in hospitals and hospital-type facilities by properly trained healthcare professionals for short term ventilation in the adult population when no FDA cleared ventilators are available during the COVID-19 pandemic.06/24/2020
			Air Boost
			AustinP51
			Emergency Resuscitator
			QOU
			The AustinP51 is a portable emergency use resuscitator designed to provide either continuous or intermittent ventilatory support for patients requiring mechanical ventilation through volume control. The AustinP51 should only be used by those professionals who are qualified and trained in the use of general ventilation equipment, or who are specifically trained on the AustinP51 system. The AustinP51 emergency use resuscitator (EURS) is intended to treat adults during the COVID-19 pandemic as authorized by the appropriate FDA EUA and should only be used when no FDA cleared or approved ventilators are available.06/26/2020
			Stewart & Stevenson Healthcare Technologies, LLC
			Apollo ABVM
			Emergency Resuscitator
			QOU
			The Apollo ABVM is an emergency use resuscitator intended for short term use under the direction of critical care physicians and respiratory therapists to provide continuous or intermittent mechanical ventilation to a patient only when an FDA-cleared clinical ventilator is not available during the COVID-19 pandemic. This device mechanically actuates a manual resuscitator and may assist patients in breathing support in order to meet emergency demands for ventilators. The Apollo ABVM is intended for application for adult patients only. The Apollo ABVM is restricted medical device intended for use in hospitals only06/26/2020
			SAGICO USA, LLC
			V2O SAGICO SYSTEM
			Ventilator, Continuous, Facility Use
			QOS
			The V2O SAGICO SYSTEM Ventilator is an electronically controlled, electronically powered machine, which is used in ICU, in Respiratory Department or Emergency Department for the rescue and therapy of the patient with respiratory insufficiency, and in other departments for providing respiratory support for the patient.  The V2O SAGICO SYSTEM is to be used only by properly trained healthcare professionals.05/01/2020
			Wilcox Industries Corp
			Wilcox PATRIOT SAVR (Amended July 21, 2020)
			Emergency Ventilator
			QOT
			PATRIOT SAVR is indicated for emergency continuous or intermittent mechanical support of adult patients when their ventilatory status cannot be maintained by high flow oxygen by nasal cannula, and a FDA cleared ventilator is not available.
			 
			Target Patients
			The SAVR is applicable for adult patients who require the general types of invasive or non-invasive ventilatory support, as prescribed by an attending doctor:
			Positive Pressure ventilation
				Assist/Control, SIMV modes of ventilation
			The SAVR provides multiple alarms states but minimal monitoring capability, and thus the level of patient criticality should be considered before use. It is not indicated for Level 3 Critical Care patients.
			 
			Target Environments
			The ventilator is suitable for use in institutional and portable settings.
			 
			Target Operators
			This ventilator must be used only under the responsibility and on the prescription of a doctor.
			The ventilator may be operated by the following caregivers:
			Respiratory therapists
				Doctors
				Nurses07/31/2020
			LifeMech, Inc.
			LifeMech A-VS
			Emergency Resuscitator
			QOU
			Intended for use by qualified, trained personnel under the direction of a physician only when an FDA-cleared clinical ventilator is not available during the COVID-19 pandemic.

			The LifeMech A-VS is an automated manual resuscitator bag designed to provide basic ventilator functionality to a single patient at a time, in an emergency situation when there are no other options available to the patient. It does not replace standard mechanical ventilation but acts as a bridge to standard mechanical ventilation. The A-VS has been designed to meet AAMI guidelines for Emergency Use Ventilators and functions with existing bag valve masks (BVM)/manual resuscitator bags. The manual resuscitator bags that are currently indicated for use with this device are:

			Ambu Spur II with POP-off valve
				Smiths Medical Portex 8500P08/04/2020
			VORTRAN Medical Technology 1, Inc
			VORTRAN GO2VENT with PEEP Valve
			Emergency Ventilator
			QOT
			The VORTRAN GO2VENT with PEEP Valve is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilator support on patients weighing 10kg and above.08/04/2020
			Nanotronics Imaging, Inc
			nHale BiPAP device (Amended October 3, 2022)
			Ventilator, Continuous, Minimal Ventilatory Support
			QOR
			The nHale BiPAP is intended to be used by healthcare providers in healthcare facilities(e.g., hospitals, assisted living facilities, nursing homes) as well as spaces converted for the care of large numbers of COVID-19 patients (e.g., convention centers, university dormitories, motels, etc.) to support spontaneously breathing adults weighing over 30kg suffering from COVID-19 disease. The nHale BiPAP is a non-invasive ventilator designed to be used in non-life-threatening situations, for spontaneously breathing patients, where a patient is in need of breathing assistance but is not in need of invasive ventilatory support based on standard medical protocols.08/07/2020
			Hillrom
			Life 2000 Ventilation System Product No. BT-V5
			Ventilator, Continuous, Facility Use
			QOS
			The Life20000 Ventilator is intended to provide continuous or Intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is 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 ET tube) or non-invasively (via mask).
				Assist/Control mode of ventilation.
			The ventilator is suitable for use in Institutional settings.08/18/2020
			Breas Medical Inc
			Z2 Bilevel
			Ventilator, Continuous, Minimal Ventilatory Support
			QOR
			The Z2 Bilevel is intended to provide continuous or intermittent ventilatory support for the care of adults who require mechanical ventilation. The Z2 Bilevel is for patients under the supervision of healthcare professionals within a healthcare facility. For invasive ventilation, the Z2 Bilevel is to be used in the Intensive Care Unit (ICU) only. For non-invasive ventilation, the Z2 Bilevel is to be used in the Emergency Room / ICU environment only. The Z2 Bilevel is provided under FDA Emergency Use Authorization (EUA) relating to the COVID-19 pandemic.08/21/2020
			MICo Medical s.r.o.
			MICo Medical CoroVent
			Emergency Ventilator
			QOT
			The CoroVent ventilation device is intended for the emergency, invasive ventilation of adult patients greater than 21 years of age, with body weight greater than 50 kg (110 lbs), and with respiratory failure due to COVID-19. The CoroVent provides pressure-limited continuous mandatory ventilation (VC-CMV) to ventilation dependent patients. The CoroVent is intended to be used by physicians in hospital facilities. The CoroVent is not a transport ventilator. The CoroVent is not cleared or approved in the United States and has been granted an Emergency Use Authorization by the FDA for use during the COVID-19 pandemic.  The CoroVent provides patients with emergency ventilatory support when no cleared or approved standard ventilators are available.09/23/2020
			Belkin International, Inc.
			Belkin FlexVent Gas Operated Emergency Ventilator (Resuscitator)
			Emergency Ventilator
			QOT
			The FlexVent is intended for use only by properly trained personnel on adult patients who require mechanically-assisted emergency, short-term constant flow, pressure cycled ventilation or resuscitation in an emergency situation or during transportation.09/18/2020
			Medicreations LLC
			MediVent ICU- MCV
			Emergency Ventilator
			QOT
			The MediVent ICU series ventilator system is intended to provide continuous or intermittent ventilation for adult patients who require invasive or noninvasive respiratory support. The MediVent ICU offers mandatory and spontaneous ventilation modes as well as respiratory monitoring. The MediVent ICU is intended for use by qualified, trained personnel under the direction of a physician in hospitals and hospital-type facilities. MediVent ICU series ventilator system is not cleared or approved in the United States and has been granted an Emergency Use Authorization by the FDA for use during the COVID-19 pandemic. The MediVent ICU series ventilator system provides patients with emergency ventilatory support when no cleared or approved standard ventilators are available.12/02/2020
			CorVent Medical, Inc.
			CorVent RESPOND 19 Ventilator
			Emergency Ventilator
			QOT
			The RESPOND 19 Ventilator is an electrically powered ventilator intended to provide continuous, invasive ventilatory support for the care of adult patients (of at least 60 lbs.) who require mechanical ventilation. The RESPOND 19 Ventilator is intended for use in a hospital, or similar clinical environments, by qualified, trained personnel under the direction of a licensed physician. Personnel must become thoroughly familiar with these instructions prior to using the RESPOND 19 Ventilator.12/04/2020
			Skanray USA
			SKANRESPIRO/SKANRESPIRO PLUS
			Emergency Ventilator
			QOT
			SKANRESPIRO Ventilator is intended for continuous and intermittent mechanical ventilation to provide positive pressure ventilatory support to Adults and Pediatrics patients aged two (2) years and above. It is intended to be used within hospital intensive care ward, recovery room, emergency medical care. SKANRESPIRO is portable and can be mounted on a trolley for intra-hospital transport. SKANRESPIRO is intended to be used by qualified and trained personnel under the supervision of Medical practitioner, within its stated technical specification.02/08/2021
			Löwenstein Medical Technology GmbH + Co. KG
			LUISA Life Support Ventilator LM150TD
			Emergency Ventilator
			QOT
			The LUISA provides continuous or intermittent ventilatory support for adult patients who require mechanical ventilation. The LUISA device is intended to be used in home, institution/hospital and portable applications for both invasive and non-invasive ventilation.

			Caution: The LUISA device is not intended for use as an emergency transport ventilator.

			Caution: In the US, Federal law restricts this device to sale by or on the order of a physician.

			The LUISA Ventilator has NOT been FDA cleared or approved. The LUISA Ventilator has been authorized by FDA under an EUA and is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergence use of ventilators, ventilator tubing connectors, and ventilator accessories under section 564(b)(1) of the Act U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

			This EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergence use of ventilators, ventilator tubing connectors, and ventilator accessories during the COVID-19 pandemic is terminated under section 564(b) (2) of the Act or the EUA is revoked under section 564(g) of the Act.02/23/2021
			DeVilbiss
			IntelliPAP/SleepCube Model DV56 ST Series Bilevel
			Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
			QOR
			The DeVilbiss IntelliPAP/SleepCube Model DV56 ST Series Bilevel is intended for use in treating OSA and respiratory insufficiency non-invasively in spontaneously breathing patients 30 Kg and above by means of application of positive air pressure. The Device is to be used in home and clinical environments.02/24/2021
			CAE Healthcare
			CaeAir1
			Emergency Ventilator
			QOT
			The CAEAir1 mechanical ventilator is indicated to provide emergency continuous invasive ventilatory support with the provision of an adjustable percentage of oxygen in the breathing gas for adult patients who require mechanical ventilation when an FDA-cleared ventilator is not available due to the COVID-19 pandemic. The ventilator is intended for use in  healthcare facilities under the direction of a physician.03/01/2021
			Nectar Product Development
			BreathDirect BDR-19
			Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
			QOR
			BreathDirect Ventilator (BDR-19) is intended to provide positive pressure ventilatory support for adults who may or may not (or no longer) need invasive ventilation.

			The BDR-19 is intended to be used in the intensive care ward, intermediate care ward, long term acute care hospital or in the recovery room. The BDR-19 is intended to be attended by a professional operator for patients who are dependent on mechanical ventilation and is intended for use in critical care environments in a professional healthcare facility.

			The BDR-19 is to be used only by order of a qualified physician and by medically qualified personnel, trained in the operation, and within the stated specification limits.

			Due to the limited battery life, the BDR-19 is not intended for use as a transport ventilation device.

			The BDR-19 is intended for a 2-year design life and is for Emergency Use Authorization (EUA) in the United States of America (USA).03/22/2021
			O2U, Inc.
			O2U Ventilator: Model 100
			Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
			QOR
			The O2U ventilator is intended to provide continuous or intermittent ventilatory support for the care of adult patients who require mechanical ventilation when an FDA-cleared ventilator is not available due to the COVID-19 pandemic. The O2U ventilator is intended to be used in a hospital or other institutional healthcare environment. The ventilator is intended to be used by qualified and trained medical professionals for use with various combinations of specified patient circuits, interfaces (mask or intubation), and other accessories. The O2U ventilator is intended for single patient use for a period of up to 7 days. It is reusable but must be returned to the manufacturer for factory service (reprocessing) after each patient use, before use on next patient.03/30/2021
			OxVent Ltd.
			AIRA V1.0
			Ventilator, Continuous, Facility Use
			QOS
			The AIRA Ventilator is indicated for the minimum ventilatory support of adult patients weighing at least 100 lbs. (45.4 kg) who require continuous ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a doctor when an FDA-cleared ventilator is not available due to the COVID-19 pandemic.04/20/2022
			DIMAR S.r.l. a Socio Unico
			Dimar NIV Helmet
			Ventilator, non-continuous, Mask
			QOQ
			The Dimar NIMV Helmet is a single use patient interface indicated for the treatment of patients requiring non-invasive mechanical ventilation respiratory support therapy. It can be employed on conscious adult patients in upright or lying position. The Dimar NIMV Helmet is intended for prescription use only in a hospital setting and limited to use with respiratory support equipment containing Respiratory Rate and Pressure alarms. The NIMV Helmet is to be used under careful monitoring by qualified healthcare providers.

Ventilators Removed from Appendix B

These ventilators had been on the list of authorized ventilators in Appendix B, but have been removed.

Date No Longer Authorized
			Manufacturer
			Ventilator Model(s) No longer Authorized
			Device Description
			Assigned Product Code06/21/2023
			GE Healthcare
			pNeuton Model A-E Ventilator
			Ventilator, Continuous, Facility Use
			QOS

Authorized Ventilator Tubing Connectors

Date of Authorization
			Manufacturer
			Product Name
			Device Description
			Assigned Product Code
			Intended Use04/19/2020
			MakeMedical
			VentMI
			Dual Patient Circuit Connector
			QOX
			A single ventilator fitted with the VentMI Ventilator Splitter can be used for two adult patients with the same pathology for ventilatory support for up to fourteen (14) days during the COVID-19 pandemic when individual ventilators are not available.04/29/2020
			Northwell Health, Inc.
			Northwell 3D Printed BiPAP Adapter
			Ventilator Tubing Connector
			QOO
			The Northwell Health 3D Printed BiPAP Adapter ("Adapter") is intended for use as an exhalation port that enables invasive use of a bilevel positive airway pressure (BiPAP) machine with a pressure control ventilation (PCV) option as a pressure-controlled ventilator.04/29/2020
			Formlabs Inc.
			Formlabs 3D Printed BiPAP Adapter
			Ventilator Tubing Connector
			QOO
			The Formlabs 3D Printed BiPAP Adapter ("Adapter") is intended for use as an exhalation port that enables invasive use of a BiPAP with a pressure control ventilation (PCV) option as a pressure-controlled ventilator.05/29/2020
			Bloom Energy
			Ventilator Sharing and Monitoring
			Patient Circuit Connector
			QOX
			The Ventilator Sharing and Monitoring System allows a single critical care ventilator to be used for up to four adult patients for ventilator support during the COVID-19 pandemic when individual ventilators are not available.

Ventilator Accessories Removed from Appendix B

These ventilator tubing connectors had been on the list of authorized ventilator tubing connectors in Appendix B, but have been removed.

Date Removed
			from Appendix B
			Manufacturer
			Ventilator Tubing Connector Model(s) No Longer Authorized08/28/2020
			Prisma Health
			Ventilation Expansion Splitter (VESper)02/09/2021
			Vent Multiplexor LLC
			Vent Multiplexor02/09/2021
			Covidien LLC
			DAR Adult Dual Patient Breathing Circuit 301P1442902/09/2021
			Safe Flight Instrument Corporation
			Safe Flight 9100-1 Quad Vent02/09/2021
			Safe Flight Instrument Corporation
			Safe Flight 9100-3 Quad Vent02/09/2021
			Stryker Instruments
			Flow Control Valve02/09/2021
			Valhalla Medical Supply, LLC
			Single-Use Emergency Ventilator 2-Way Manifold02/09/2021
			The New Bureau
			The Single Path Airway Rapid Retrofit Optional Workflow ("Sparrow") COVID-19 Co-Ventilator Assist Device02/09/2021
			Dr. Bryan Lai
			VentSplitter Emergency Ventilator Circuit Splitter and Flow Limiters03/27/2022
			Great Group Medical Co., LTD
			GGM Breathing Circuit Bacterial Filter; Models: VH-3110 (Model: Adult with luer port), VH-3210 (Model: Adult/Child with luer port), VH-3211 (Model: Adult/Child without luer port), VH-3310 (Model: Pediatric with luer port); and Bacterial / Virial Respirator Filters: VF-2150 (Model: Adult), VF-2151 (Model: Adult/Child), VF-2152 (Model: Adult/Child), VF-2153 (Adult/Child without port), VF-2160 (Model: Adult without port), VF-2160-1 (Adult with port)10/03/2023
			Vapotherm Inc
			HVT2.0

Authorized Ventilator Accessories

Date of Authorization
			Manufacturer
			Product Name
			Device Description
			Assigned Product Code
			Intended Use04/13/2020
			SMD Manufacturing, LLC
			ReddyPort Mini NIV Access Elbow
			Elbow Connector for Mask
			QOO
			The ReddyPort Mini NIV Access Elbow is intended to provide an interface for application of CPAP or bi-level therapy. The elbow is for single patient use in the hospital/institutional environment. The elbow is to be used on patients 7 years or older (>40lbs/18.2kg) for whom CPAP or bi-level therapy has been prescribed04/14/2020
			3B Medical, Inc.
			3B Hi-Flow H80
			Respiratory Humidifier
			QOP
			H-80 series humidifier is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases. This device is for patients by prescription in the home or hospital/institutional environment. The device is only allowed to be used after the physician provides guidance for the patient and targeted setting of the device; the physician should ensure that the patient understands all functions and methods of operation of the device.04/28/2020
			Janisys
			Janisys CPAP Flow Generator
			Positive End Expiratory Pressure Breathing Attachment
			QOO
			The Janisys CPAP Flow Generator, when used in conjunction with a PEEP valve, is used to provide CPAP to a spontaneously breathing adult in hospital settings. The DD-3 variable-flow model is intended to provide 28%-100% FIO2 and the DD-4 fixed-flow model is intended to provide 28%-33% FIO2.05/20/2020
			Vincent Medical Manufacturing Co., Ltd
			O2FLO High Flow Respiratory Humidifier (VUN-001)
			Respiratory Humidifier
			QOP
			The O2FLO High Flow Heated Respiratory Humidifier (VUN-001) is intended to deliver warmed and humidified respiratory gases to spontaneously breathing patients with a flow rate from 2LPM to 60LPM and is capable of providing high flow therapy. The device can be used in the emergency room, outpatient department, inpatient department and other diagnostic and treatment rooms.06/23/2020
			Vincent Medical (Dong Guan) Manufacturing. Co., LTD.
			Heat and Moisture Exchanging Filters (HMEF): HMEF 1000 Straight (Model 504-011, part number 51008027), HMEF 1000 Angled (Model 504-011, part number 51008028), HMEF Midi Straight (Model 504-011, part number 51008029), HMEF Midi Angled (Model 504-011, part number 51008030); and Bacterial / Viral Respirator Filters: BSF103 low resistance (Model 510-014, part number 51008082) and BSF201 High performance (Model 504-011, part number 51008083)
			Breathing Circuit Filters
			QPH
			HME / Filter - For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired and to maintain moisture levels in the patient's respiratory tract during anesthesia, artificial respiration, and other types of assisted ventilation. Use up to 24 hours. For adults with Tidal Volumes > 300 ml.

			Filter only - For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired. Use up to 24 hours. For adults with tidal volume > 300 ml.07/08/2020
			Circadiance
			SleepWeaver Prevent Mask
			Ventilator, non-continuous, Mask
			QOW
			The SleepWeaver Prevent Nasal Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or Bi-Level therapy. This mask is intended for single-patient reuse in the home and single-patient reuse in the hospital / institutional environment. This mask is to be used on patients greater than 66 lbs (30 kg). The filter mask present in SleepWeaver Prevent is intended to filter exhaled air to reduce the likelihood that the exhaled air may contaminate the room air around the person using the mask.07/17/2020
			Great Group Medical (GGM)
			GGM Respiratory Humidifier, Models VH-2100, VH2600A, and VH-2600
			Respiratory Humidifier
			QOP
			The GGM Respiratory Humidifier is intended to warm and add humidity to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance via an endotracheal tube or face mask. For use by trained personnel only within a hospital/institutional environment. This device is intended to be used only with the GGM Respiratory Humidifier Heated Wire Breathing System and GGM Respiratory Humidification Chamber.08/04/2020
			Lombardi Undersea LLC
			Subsalve Oxygen Treatment Hood
			Ventilator, non-continuous, Mask
			QOW
			The Subsalve Oxygen Treatment Hood is a patient interface intended for helmet based Non Invasive Positive Pressure Ventilation (NIPPV) according to clinician established protocols to treat Acute Respiratory Distress Symptoms (ARDS) resulting from COVID-19. The device is for adults only and intended for use in Intensive Care Unit (ICU) settings.08/07/2020
			Prudent American Technologies, Inc
			Fixed Resistance Connector Valve
			Ventilator Tubing Connector
			QOO
			The Fixed Connector Resistance Valve as a part of the Adaptable BiPAP Circuit (ABC) is intended for use on adult patients suffering from acute respiratory distress or insufficiency. The ABC can be substituted for FDA-cleared BiPAP breathing circuits with an exhalation port in cases where these FDA-cleared circuits are unavailable due to shortages during the COVID-19 pandemic. For use in bilevel ventilation, continuous positive airway pressure (CPAP), or invasive mechanical ventilation in pressure control modes with PEEP above 5 cmH2O. The ABC facilitates invasive mechanical ventilation and non-invasive ventilation with the support of a bilevel positive airway pressure (BiPAP) machine. When treating COVID patients, any bilevel breathing circuit should be used with a non-vented anti-asphyxiation valve mask with an appropriate viral filter on the exhalation port.08/12/2020
			Covidien, LLC
			Puritan Bennet Reusable Pediatric-Adult Expiratory Filter
			Breathing Circuit Filters
			QPH
			The Puritan Bennett Reusable Pediatric-Adult Expiratory Filter is designed for the Puritan Bennett 980 Series Ventilator (hereafter "PB980 Ventilator") to prevent bacteria in the patient's exhaled gas from venting to room air.08/14/2020
			Intersurgical, Inc
			Intersurgical StarMed CaStar R Hood for NIV
			Ventilator, non-continuous, Mask
			QOW
			Helmet for non-invasive ventilation and CPAP in hospital environment. The treatment may only be performed under careful monitoring by expert operators. Suitable for treatment of respiratory insufficiency in hypoxemic / hypercapnic adult patients.10/16/2020
			Invent Medical Corporation
			High Flow Humidifier (HFT-150)
			Respiratory Humidifier
			QOP
			HFT 150 system is for spontaneously breathing adult patients who would benefit from receiving high flow warmed and humidified respiratory gases. The flow may be from 2 - 60 L/min depending on the patient interface. The HFT 150 is used in hospital and long-term care facilities.11/23/2020
			Azimuth Sleep Solutions
			PortPatch
			Ventilator, non-continuous, Mask
			QOW
			PortPatch is intended to reduce the spread of airborne particulates through the exhalation ports, anti-asphyxia valves and carbon dioxide vents on full-face or non-rebreathing CPAP and other ventilation masks.01/06/2021
			Vyaire Medical, Inc.
			Sterile Water for Humidifier
			Respiratory Humidifier
			QOP
			The Sterile Water for Humidifier is intended to provide a supply of sterile water to unfilled respiratory humidifier chambers for inhalation purposes.

			It is intended to be used in institutional and non-institutional care settings. It is substitute to the sterile water intended to be used for inhalation with a mechanical ventilator, when these devices are not available.02/02/2021
			Pall Medical
			Breathing Circuit Filter
			Breathing Circuit Filters
			QPH
			The Pall Breathing Circuit Filter model BB22-15A is a single use bi-directional bacterial/viral removal filter and heat and moisture exchanger that is indicated for providing machine side filtration on ventilators with a gas outlet fitting that complies with ISO 5356-1 and where filtration of inspired and/or expired gases is desired to protect the patient, staff and/or interior of the breathing system from patient-derived contamination during assisted ventilation. Intended for single use of up to 24 hours, in conjunction with a hospital protocol that ensures hygienic and mechanical integrity of the system. Provides greater than 99.999% bacterial and viral efficiency.03/15/2021
			Great Group Medical Co., Ltd.
			Disposable Heater Wire Breathing Circuit
			Respiratory Humidifier
			QOP
			The heated wire breathing system is intended to deliver the gas that is humidified and heated by the humidifier chamber. The humidified and heated gas from the humidifier chamber to deliver to the patient airway is through the heater wire to maintain or heat up the temperature. It is compatible with GGM Respiratory Humidifier (EUA200690) through the connection of GGM heater wire adapter.

			For those patients who need mechanical ventilation, positive airway pressure assistance, or general medical gases.03/19/2021
			Vyaire Medical, Inc.
			AirLife DuoTherm Humidification System
			Respiratory Humidifier
			QOP
			The AirLife DuoTherm Humidification System delivers heated, humidified respiratory gases to patients receiving invasive or non-invasive therapy. It is intended for adult patients only within the scope of this EUA submission. The device is intended to be used in professional healthcare environments under the supervision of a licensed healthcare practitioner.04/28/2021
			PEEP-Alert Technologies, Inc.
			PEEP-Alert Pressure and Flow Monitor
			Positive End Expiratory Pressure Breathing Attachment
			QOO
			The PEEP-Alert Pressure and Flow Monitor is a non-patient contacting medical device that measures and displays delivered positive end-expiratory pressure (PEEP) and gas flow. PEEP-Alert is designed for use with a ventilatory assistance helmet (VAH) as used in the intensive care unit, clinic, and emergency settings for adult and pediatric patients. PEEP-Alert has audible and visual indicators if delivered PEEP and gas flow do not reflect the clinician's setting. Alarm settings for the minimum and maximum delivered PEEP and fresh gas flowrate should be set by the clinician based upon their assessment of the patient's respiratory requirements.04/20/2022
			DIMAR S.r.l. a Socio Unico
			Dimar CPAP Helmet
			Ventilator, non-continuous, Mask
			QOO
			The Dimar CPAP Helmet is a single use patient interface indicated for the treatment of patients requiring Continuous Positive Airway Pressure respiratory support therapy. It can be employed on conscious adult patients in upright and lying position. The Dimar CPAP Helmet is intended for prescription use only in a hospital setting.

                                                                                  Content current as of:
      01/19/2024
              
              
Regulated Product(s)
		 Medical DevicesHealth Topic(s)
			  CoronavirusCOVID-19 Emergency Use Authorizations for Medical Devices

          
                        Blood Purification Devices EUAs
          Continuous Renal Replacement Therapy and Hemodialysis Devices EUAs
          In Vitro Diagnostics EUAs
          Infusion Pump EUAs
          Personal Protective Equipment EUAs
          Remote or Wearable Patient Monitoring Devices EUAs
          Respiratory Assist Devices EUAs
          Ventilators and Ventilator Accessories EUAs
          Other Medical Device EUAs
 
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