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
Contact person:Stephen
Phone:+86-18123902349
Emai:[email protected]
Name:kn95 mask
Add:Shenzhen,Guangdong,China