O-Two 01CV8019-CS

GUDID 17540195005218

The O-Two single-use ventilation circuit is designed to be used with ventilators, demand valve or gas mixers to deliver oxygen or nitrous oxide and oxygen mixture gas to patients. It consists of one corrugated breathing hose, an inspiratory one-way valve, and a PEEP port. The 01CV8019 with anti-entrainment flapper and facemask/mouth piece is specifically designed for use with O-Two Equinox Relieve and Equinox Advantage nitrous oxide and oxygen gas mixing and delivery units.

O-Two Medical Technologies Inc

Ventilator breathing circuit, single-use
Primary Device ID17540195005218
NIH Device Record Key36f5098e-6cb1-464c-98aa-3866f03226e2
Commercial Distribution StatusIn Commercial Distribution
Brand NameO-Two
Version Model Number01CV8019
Catalog Number01CV8019-CS
Company DUNS206449154
Company NameO-Two Medical Technologies Inc
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-387-3405
Email[email protected]

Device Dimensions

Length40 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107540195005211 [Primary]
GS117540195005218 [Package]
Contains: 07540195005211
Package: [10 Units]
In Commercial Distribution

FDA Product Code

CAICircuit, Breathing (W Connector, Adaptor, Y Piece)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-27
Device Publish Date2019-05-31

On-Brand Devices [O-Two]

17540195004518The Child Ventilation Timer is intended to guide the rescuer to provide ventilation at a rate appropriate for child patients. The green LED light on the 01BM1500 is powered by a 3.0V coin battery to provide a 20 BPM flashing rate (1.0 sec ON and 2.0 sec OFF)
17540195004501The Adult Ventilation Timer is intended to guide the rescuer to provide ventilation at a rate appropriate for adult patients.The LED light on the 01BM1000 is powered by a 3.0V coin battery to provide 10BPM flashing rate (1.5 sec ON, 4.5 sec OFF).
07540195054219The Multi Patient Unit is intended for delivery of adjustable oxygen therapy flow rates (0-15 L/min) to a maximum of six patients via oxygen therapy masks. It also has a self-sealing outlet for connection of an additional respiratory therapy or ventilation device.The Multi Patient Unit is packed with 25’ Oxygen supply hose, Medium concentration masks and Oxygen tubing.
17540195010359The Single-use cuff mask comes with an air cushion pad to provide comfort for the patient. It is designed to be positioned over a patient’s nose or mouth to direct oxygen or anesthetic gases or aerosols to the upper airway. The size #4 cuff mask 02FM5203 fits Adult patients.
17540195010342The Single-use cuff mask comes with an air cushion pad to provide comfort for the patient. It is designed to be positioned over a patient’s nose or mouth to direct oxygen or anesthetic gases or aerosols to the upper airway. The size #5 cuff mask 02FM5208 fits large Adult patients.
17540195010335The Single-use cuff mask comes with an air cushion pad to provide comfort for the patient. It is designed to be positioned over a patient’s nose or mouth to direct oxygen or anesthetic gases or aerosols to the upper airway. The size #3 cuff mask 02FM5203 fits small Adult patients.
17540195010328The Single-use cuff mask comes with an air cushion pad to provide comfort for the patient. It is designed to be positioned over a patient’s nose or mouth to direct oxygen or anesthetic gases or aerosols to the upper airway. The size #0 cuff mask 02FM5203 fits Neonate patients.
07540195010314The Single-use cuff mask comes with an air cushion pad to provide comfort for the patient. It is designed to be positioned over a patient’s nose or mouth to direct oxygen or anesthetic gases or aerosols to the upper airway. The size #1 cuff mask 02FM5205 fits Infant patients.
07540195010307The Single-use cuff mask comes with an air cushion pad to provide comfort for the patient. It is designed to be positioned over a patient’s nose or mouth to direct oxygen or anesthetic gases or aerosols to the upper airway. The size #2 cuff mask 02FM5203 fits Child patients.
17540195010151O-Two Resuscitation and Anesthesia Facemasks are intended to be used with automatic ventilator/manual resuscitator or anesthesia machine to provide a mask to face seal which covers both mouth and nose during resuscitation or anesthesia. The clear Silicone facemasks are ideal for anesthesia as they withstand repeated autoclaving. The Neonate Silicone Face Mask 02FM5102 fits neonate patients.
17540195010144O-Two Resuscitation and Anesthesia Facemasks are intended to be used with automatic ventilator/manual resuscitator or anesthesia machine to provide a mask to face seal which covers both mouth and nose during resuscitation or anesthesia. The clear Silicone facemasks are ideal for anesthesia as they withstand repeated autoclaving. The Infant Silicone Face Mask 02FM5101 fits infant patients.
07540195010130O-Two Resuscitation and Anesthesia Facemasks are intended to be used with automatic ventilator/manual resuscitator or anesthesia machine to provide a mask to face seal which covers both mouth and nose during resuscitation or anesthesia. The clear Silicone facemasks are ideal for anesthesia as they withstand repeated autoclaving. The Child Silicone Face Mask 02FM5097 fits child patients.
17540195010120O-Two Resuscitation and Anesthesia Facemasks are intended to be used with automatic ventilator/manual resuscitator or anesthesia machine to provide a mask to face seal which covers both mouth and nose during resuscitation or anesthesia. The clear Silicone facemasks are ideal for anesthesia as they withstand repeated autoclaving. The large silicone mask 02FM5099 fits Adult patients.
17540195010113O-Two Resuscitation and Anesthesia Facemasks are intended to be used with automatic ventilator/manual resuscitator or anesthesia machine to provide a mask to face seal which covers both mouth and nose during resuscitation or anesthesia. The clear Silicone facemasks are ideal for anesthesia as they withstand repeated autoclaving. The medium silicone mask 02FM5098 fits patients from large Child to small Adult.
17540195010106O-Two Resuscitation and Anesthesia Facemasks are intended to be used with automatic ventilator/manual resuscitator or anesthesia machine to provide a mask to face seal which covers both mouth and nose during resuscitation or anesthesia. The clear Silicone facemasks are ideal for anesthesia as they withstand repeated autoclaving. The universal silicone mask 02FM5097 fits patients from infant to Adult adult.
17540195010038O-Two Resuscitation and Anesthesia Facemasks are intended to be used with automatic ventilator/manual resuscitator or anesthesia machine to provide a mask to face seal which covers both mouth and nose during resuscitation or anesthesia. The clear PVC facemask is ideal for use where disinfection after use is normally undertaken by cold chemical sterilant.The Large mask 02FM5001 fits adult patients.
07540195010024O-Two Resuscitation and Anesthesia Facemasks are intended to be used with automatic ventilator/manual resuscitator or anesthesia machine to provide a mask to face seal which covers both mouth and nose during resuscitation or anesthesia. The clear PVC facemask is ideal for use where disinfection after use is normally undertaken by cold chemical sterilant. The medium mask 02FM5000 fits adult patients.
17540195010014O-Two Resuscitation and Anesthesia Facemasks are intended to be used with automatic ventilator/manual resuscitator or anesthesia machine to provide a mask to face seal which covers both mouth and nose during resuscitation or anesthesia. The clear PVC facemask is ideal for use where disinfection after use is normally undertaken by cold chemical sterilant.The universal mask 02FM4999 fits patients from Adult to infant.
07540195071322The Single-use Adult Nasal Cannula with Tubing is used to deliver supplemental oxygen to an adult patient in need of respiratory help. This device consists of a nose prong, a thin tube, a quick disconnector and oxygen tubing.
07540195071308The Single-use Adult Nasal Cannula is used to deliver supplemental oxygen to an adult patient in need of respiratory help. This device consists of a nose prong and a thin tube.
07540195070219The Single-use Adult Medium Concentration Mask with Tubing is used to provide respiratory therapy. It is achieved by connecting the device to an oxygen gas supply. The adult patient can inhale various concentration of oxygen through the mask.
07540195070202The Single-use Adult Medium Concentration Mask is used to provide respiratory therapy. It is achieved by connecting the device to an oxygen gas supply. The adult patient can inhale various concentration of oxygen through the mask.
17540195005331The O-Two single-use electronic ventilator ventilation circuit consists of a single ventilation corrugated hose and equipped with a flow sensor adapter designed to stream the flow without turbulence and create a differential pressure in two points which are connected to differential pressure sensor used to calculate flow. The unique one-way check valve will only allow flow from ventilator to patient and prevent the exhaled flow flowing back to the ventilator. All exhaled flow will be forced out to the atmosphere through the exhausted port of the breathing valve. The 01CV8030 is specifically designed for use with o_two e700, e600 and e500 electronic transport ventilators.
17540195005218The O-Two single-use ventilation circuit is designed to be used with ventilators, demand valve or gas mixers to deliver oxygen or nitrous oxide and oxygen mixture gas to patients. It consists of one corrugated breathing hose, an inspiratory one-way valve, and a PEEP port. The 01CV8019 with anti-entrainment flapper and facemask/mouth piece is specifically designed for use with O-Two Equinox Relieve and Equinox Advantage nitrous oxide and oxygen gas mixing and delivery units.
17540195005188The O-Two single-use ventilation circuit is designed to be used with ventilators, demand valve or gas mixers to deliver oxygen or nitrous oxide and oxygen mixture gas to patients. It consists of one corrugated breathing hose, an inspiratory one-way valve, and a PEEP port. The 01CV8016 is specifically designed for use with CAREvent MRI ventilators and is long enough to allow free passage of the patient in and out of the MRI unit without the risk of pulling on the tubing.
17540195005171The O-Two single-use ventilation circuit is designed to be used with ventilators, demand valve or gas mixers to deliver oxygen or nitrous oxide and oxygen mixture gas to patients. It consists of one corrugated breathing hose, an inspiratory one-way valve, and a PEEP port. The 01CV8015 with anti-entrainment flapper is specifically designed for use on O-Two automatic resuscitators and transport ventilators and other ventilators that respond to the spontaneous breathing.
07540195005129The O-Two single-use ventilation circuit is designed to be used with ventilators, demand valve or gas mixers to deliver oxygen or nitrous oxide and oxygen mixture gas to patients. It consists of one corrugated breathing hose, an inspiratory one-way valve. The 01CV8010 is specifically designed for use on Bag-Valve-Mask resuscitators and ventilators without demand breathing or patient triggered ventilation modes.

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