Authorized Ventilators Ventilator Tubing Connectors and Ventilator Accessories

Appendix B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories

Updated: May 8, 2020

To be added to Appendix B (below), ventilators, ventilator tubing connectors, and ventilator

accessories must be determined to meet the applicable conditions and criteria for safety, performance

and labeling set forth in Section II, Section IV, and Appendix A. FDA will add a ventilator, ventilator

tubing connector, and ventilator accessory to the list of authorized products in Appendix B (below)

upon submission of a request from a sponsor as described in the Scope of Authorization Section of the

Letter of Authorization (Section II) and pursuant to the Conditions of Authorization (Section IV) in this

EUA and based on FDA’s review and concurrence.

Ventilators

Manufacturer Product Name Device

Description

Intended Use Date of

Authorizatio

n

Beijing

Aeonmed Co.,

Ltd

VG70 ventilator Critical Care

Ventilator

Mechanical ventilation of patients in

ICU

March 25,

2020

Shenzen

Mindray Biomedical

Electronics

Mindray

SV300/SV600/SV8

00 ventilators

Critical Care

Ventilator

This product is intended to provide

ventilation assistance and breathing

support for adult,

pediatric and infant patients

March 28,

2020

Vyaire Medical,

Inc.

LTV2 model 2200

and LTV model

2150

Critical Care

Ventilator

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. The Model 2200 can

operate with high O2. The Model

2150 operates with low pressure.

March 28,

2020

RESMED Stellar 150 Ventilator,

Continuous,

Minimal

Ventilatory

Support, Facility

Use

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

March 30,

2020

RESMED Lumis 150 VPAP

ST

Ventilator,

Continuous,

Minimal

Ventilatory

Support, Facility

Use

The ResMed Lumis 150 VPAP ST

devices are indicated to provide noninvasive 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.

March 30,

2020

Amended

April 17, 2020

RESMED GA ST Ventilator,

Continuous,

Minimal

Ventilatory

Support, Facility

Use

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.

March 31,

2020

RESMED Flexo Bi-Level ST Ventilator,

Continuous,

Minimal

Ventilatory

Support, Facility

Use

Flexo Bi-level positive airway

pressure therapy device is used to

provide non‐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 bi‐

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.

March 31,

2020

RESMED AirCurve

ST

Ventilator,

Continuous,

Minimal

AirCurve ST device has indications

for use that include respiratory

insufficiency.

March 31,

2020

Amended

Ventilatory

Support, Facility

Use

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.

April 17, 2020

Amsino YUWELL®

YH-730 Bi-level

PAP and YH-830

Bi-level PAP

Ventilator, NonContinuous

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.

March 31,

2020

Inovytec Ventway SparrowVentilator,

Continuous

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.

March 31,

2020

Philips

Respironics

VX850 VentilatorCritical Care

Ventilator

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.

April 1, 2020

BMC Medical

CO., LTD

Luna G3 BPAP

25A- LG3700

Ventilator,

Continuous,

Minimal

Ventilatory

The G3 B25A BPAP System is a Bilevel PAP (Bi-level Positive Airway

Pressure) device, which is intended

to provide non-invasive ventilation

April 2, 2020

Support, Facility

Use

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.

BMC Medical

Co., Ltd.

Y-30T Ventilator,

Continuous,

Minimal

Ventilatory

Support, Facility

Use

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.

April 2, 2020

Dragerwerk

AG & CO.

KGaA

Evita V800 and

Evita V600

Critical Care

Ventilator

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 monitoring

April 2, 2020

Dragerwerk

AG & CO.

KGaA

Babylog VN800

and VN600

Critical Care

Ventilator

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.

April 3, 2020

GE Healthcare pNeuton Model

A-E Ventilator

Ventilator,

Continuous,

Facility Use

The pNeuton Ventilator is intended

for continuous mechanical

ventilation of patients in the

following patient populations and use

locations: Patient population - adult /

pediatric patients 23 Kg and greater

who require the following general

types of ventilatory support:

• positive pressure ventilation

delivered invasively (via an ET tube)

or non-invasively (via a mask)

•CMV and IMV modes of ventilation

•with or without PEEP / CPAP

•with oxygen or a mixture of air and

April 3, 2020

oxygen

The ventilator is suitable for use in:

•Hospitals and alternate care units to

meet the needs for mechanical

ventilation

•Pre-hospital transport applications

including accident scene, emergency

rescue vehicles

•Hospital ICU transport applications

including emergency, radiology,

surgery and post anesthesia/recovery

•Air transport via helicopter or fixed

wing

Covidien LLC Puritan Bennett

560 Ventilator

System

Ventilator,

Continuous,

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 noninvasive 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.

April 5, 2020

CoLabs COVID Ventor Emergency

Ventilator

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. The

COVID Ventor System consists of

the reusable Ventor Console

(Console) and the single use,

disposable Ventor-Specific Breathing

April 6, 2020

Circuit (Breathing Circuit). The

COVID Ventor is able to provide

Pressure Controlled, Pressure

Supported, and Volume Controlled

long-term ventilatory support in

emergency situations

MEKICS Co,.

Ltd

MTV1000

ventilator

Ventilator,

Continuous

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.

April 6, 2020

Drägerwerk

AG & Co.

KGaA

Atlan A350 and

Atlan A350 XL

Gas-Machine,

Anesthesia

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 system

The following options are

additionally available:

– Patient-gas measurement module

for O2, CO2, N2O, and anesthetic

gases

– O2 insufflation

Anesthesia 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 (lowflow or minimum-flow).

April 7, 2020

VenTec Life

Systems

V+Pro

Emergency

Ventilator

Ventilator,

Continuous

VOCSN Unified Respiratory System

is intended to provide continuous or

intermittent ventilatory support for

April 7, 2020

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.

AMBULANC

TECH.CO.,LT

D

Models 6000S,

T5, T7

Emergency

Transport

Ventilator

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 inhospital 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 outof-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.

April 8, 2020

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), noninvasive (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.

Philips

Respironics

E30 ventilator Ventilator,

Continuous,

Minimal

Ventilatory

Support, Facility

Use

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.

April 8, 2020

Incoba LLC Apogee Oxygen

Conserver

The Apogee gas conserver is

intended as a delivery device for

medical grade oxygen from highApril 8, 2020

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.

SecondBreath

LLC

Pneumatic

Resuscitator device

Emergency

Resuscitator

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

April 13, 2020

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 endtidal 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.

University of

Minnesota

Medical

School and

Boston

Scientific

Corporation

Coventor Adult

Manual

Resuscitator

Compressor

Emergency

Resuscitator

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.

April 14, 2020

Umbulizer UMV-001 EUA Emergency

Resuscitator

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 prehospital, field hospital, and transport

environments, as well as hospital

settings where sufficient standard

ventilators are not available.

April 14, 2020

Hillrom MetaNeb 4 Intermittent

Positive Pressure

Breathing Device

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 – 5 years old and above

whom can follow verbal instructions.

Environment of Use – Hospitals, subacute and nursing facilities, physician

offices, clinics, and home settings.

April 16, 2020

Spiro Devices

LLC

Spiro Wave Emergency

Resuscitator

The Spiro Wave is an automated

manual resuscitator that has been

designed specifically to meet AAMI

guidelines for emergency use

resuscitators and provide respiratory

April 17, 2020

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.

RESMED AirCurve 10 ST-A Ventilator,

Continuous,

Minimal

Ventilatory

Support, Facility

Use

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.

April 17, 2020

PVA PREVENT Emergency

Resuscitator

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.

April 17, 2020

3B Medical

Inc

Luna G3 B30VT Ventilator,

Continuous,

Minimal

Ventilatory

Support

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.

April 20, 2020

Resvent iBreeze PAP Ventilator,

Continuous,

Minimal

Ventilatory

The iBreeze PAP system delivers

positive airway pressure therapy for

the treatment of Obstructive Sleep

Apnea (OSA) in spontaneously

April 20, 2020

Support, Facility

Use

breathing patients weighting over

30kg (66lbs) for use in the home,

hospital, or institutional environment.

Virgin Orbit Virgin Orbit

Resuscitator

Emergency

Resuscitator

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.

April 22, 2020

Amended

April 23, 2020

Amsino

International

Inc’s

YUWELL YH-725

BiPAP

Ventilator, NonContinuous

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.

April 23, 2020

AutoMedX Inc. SAVe II Series

Ventilator

Powered

Emergency

Ventilator

The SAVe II series are intended to

provide ventilatory support for adults

during CPR or when PositivePressure 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.

April 24, 2020

SLS Medical

Technology

Corp. Ltd.

CP101/CP101S

Series

Ventilator, NonContinuous

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.

April 24, 2020

Zhejiang

LifeMed

Technology

Co., Ltd.

LA Series

Ventilators LA20C,

LA20A, LA20B,

LA20B, LA25B,

LA25B

Ventilator, NonContinuous

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

April 24, 2020

patient.

Resvent

Medical

Technology

CO., Ltd’s

iBreeze 30STA

device

Ventilator, NonContinuous

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.

April 27, 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, NonContinuous

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.

April 28, 2020

NASA Jet

Propulsion

Laboratory

VITAL ventilator Emergency

Ventilator

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.

April 30, 2020

Venti-Now Venti-Now

Resuscitator

Model JM-P2020A

Emergency

Resuscitator

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,

April 30, 2020

trained personnel under the direction

of a Physician for COVID19/Emergency use when no FDAcleared 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.

Wilcox

Industries Corp

Wilcox PATRIOT

SAVR

Emergency

Ventilator

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

May 1, 2020

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

• Nurses

Elemaster

S.p.A.

Tecnologie

Elettroniche

Mechanical

Ventilator Milano

(MVM)

Emergency

Ventilator

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).

May 1, 2020

BMC Medical

CO., LTD.,

China

Luna G3 BPAP

S/T- LG3800-G3

B30VT

Ventilator,

Continuous,

Minimal

Ventilatory

Support

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 hospitaltype facilities, which provide

respiratory care for patients

requiring respiratory support.

May 2, 2020

ZIBO

ZHONGXUN

MEDICAL

EQUIPMENT

CO. LTD

ZXH-550 Emergency

Ventilator

The ventilator is intended to

provide continuous ventilatory

support for adult patients who

require mechanical

ventilation. The ventilator is a

May 2, 2020

restricted medical device intended

for use in hospitals and hospitaltype facilities, which provide

respiratory care for patients

requiring respiratory support.

JIUXIN

MEDICAL

JIXI H-100 Emergency

Ventilator

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 hospitaltype facilities, which provide

respiratory care for patients

requiring respiratory support.

May 2, 2020

Vayu Global

Health

Innovations

Vayu bubble

Continuous

Positive Airway

Pressure Circuit

(“Vayu bCPAP’)

Continuous

Positive Airway

Pressure Circuit

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.

May 5, 2020

Hunan Beyond

Medical

Technology

Co., Ltd

BEYOND C20A

CPAP

Ventilator,

Continuous,

Minimal

Ventilatory

Support

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.

May 6, 2020

Hunan Beyond

Medical

Technology

Co., Ltd

BEYOND B30P

BiPAP

Ventilator,

Continuous,

Minimal

Ventilatory

Support

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.

May 6, 2020

Guangzhou

Hypnus

Healthcare Co.,

Ltd.

Hypnus ST730 Ventilator,

Continuous,

Minimal

Ventilatory

Support

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.

May 6, 2020

AutoMedX Inc. SAVe II+

(M50016,

M50017)

Powered

Emergency

Ventilator

The SAVe II series are intended to

provide ventilatory support for adults

during CPR or when PositivePressure 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.

May 7, 2020

Taiyuan

Shanghai

Medical

Fabius Plus /

Fabius Plus XL

Gas Machine,

Anesthesia

Fabius plus is an inhalation

anesthesia workstation

for 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

May 8, 2020

electrically driven and

electronically controlled

ventilator and

monitors for airway pressure (P),

volume (V), and inspiratory

oxygen concentration (FiO2).

Somnetics

International,

Inc.

Transcend 3

BiPAP

Ventilator, NonContinuous

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.

May 8, 2020

Ventilator Tubing Connectors

Manufacturer Product Name Device Description Intended Use Date of

Authorization

Prisma Health Ventilation

Expansion Splitter

(VESper)

VESper allows multiple

patients to be treated by a

single ventilator

A single ventilator fitted

with the Vent Splitter can

be used for multiple

patients for ventilatory

support during the

COVID-19 pandemic

when individual ventilators

are not available or

preemptively to increase

the potential of single-use

ventilators permitting

mechanical ventilation for

multiple patients

simultaneously

March 25,

2020

Vent

Multiplexor

LLC

Vent Multiplexor Dual Patient Circuit

Connector

The Vent Multiplexor is

intended to provide

temporary rescue

mechanical ventilation for

dual patient ventilation

until an additional

ventilator is available to

resume single mechanical

ventilation or as soon as

respiratory recovery is

attained in either patient.

April 15, 2020

MakeMedical VentMI Dual Patient Circuit

Connector

A single ventilator fitted

with the VentMI Ventilator

April 19, 2020

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.

Northwell

Health, Inc.

Northwell 3D

Printed BiPAP

Adapter

Ventilator Tubing Connector 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.

April 29, 2020

Formlabs Inc. Formlabs 3D

Printed BiPAP

Adapter

Ventilator Tubing Connector 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 pressurecontrolled ventilator.

April 29, 2020

Covidien LLC DAR Adult Dual

Patient Breathing

Circuit 301P14429

Dual Patient Circuit

Connector

The Adult Dual Breathing

Circuit can be used for two

patients for ventilatory

support during the

COVID-19 pandemic

when individual ventilators

are not available to

increase the potential of

single-use ventilators

permitting mechanical

ventilation for two patients

simultaneously.

May 5, 2020

Safe Flight

Instrument

Corporation

Safe Flight 9100-3

Quad Vent

Patient Circuit

Connector

The intended use of the

Safe Flight 9100-3

Quad/Vent ventilator

splitter is to enable a single

ventilator to be shared

between multiple patients

for ventilatory support. Is

intended to provide

temporary rescue

mechanical ventilation for

multi-patient ventilation

only when single

mechanical ventilation is

not possible due to

May 7, 2020

shortage.

Safe Flight

Instrument

Corporation

Safe Flight 9100-1

Quad Vent

Patient Circuit

Connector

The intended use of the

Safe Flight 9100-1

Quad/Vent ventilator

splitter is to enable a single

ventilator to be shared

between multiple patients

for ventilatory support. Is

intended to provide

temporary rescue

mechanical ventilation for

multi-patient ventilation

only when single

mechanical ventilation is

not possible due to

shortage.

May 7, 2020

Stryker

Instruments

Flow Control Valve Patient Circuit

Connector

The Flow Control Valve is

intended for use on

patients suffering from

acute respiratory

failure. During the

COVID-19 pandemic,

when the number of

patients requiring

ventilation exceeds the

number of ventilators, the

Flow Control Valve

enables a single ventilator

to be used to provide

ventilator support to two

patients. The Flow Control

Valve is used to regulate

the flow once the breathing

circuit has already been

split by a T-piece. This

device is only intended to

be used in the setting of an

acute shortage of

ventilators, as a lifesaving

measure to provide acute

ventilatory support in

times of scarcity when

other standard single

ventilators are not

available. The Flow

Control Valve is only

suitable for use with

ventilators that have

separate inspiratory and

May 8, 2020

Ventilator Accessories

Manufacturer Product Name Device Description Intended Use Date of

Authorization

SMD

Manufacturing,

LLC

ReddyPort Mini

NIV Access Elbow

Elbow Connector for Mask The ReddyPort Mini NIV

Access Elbow is intended

to provide an interface for

application of CPAP or bilevel 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 prescribed

April 13, 2020

3B Medical,

Inc.

3B Hi-Flow H80 Respiratory Humidifier 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.

April 14, 2020

Janisys Janisys CPAP Flow

Generator

Positive End Expiratory

Pressure Breathing

Attachment

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

April 28, 2020

expiratory ports, such as

Critical Care Ventilators

and Anesthesia machines.

intended to provide 28%-

33% FIO2.

Authorized Ventilators Ventilator Tubing Connectors and Ventilator Accessories