otwo.comEquinox Advantage
O-Two Medical Technologies Inc.
O-TWO MEDICAL TECHNOLOGIES, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 9610861 | 3002807836 | O-TWO MEDICAL TECHNOLOGIES, INC. | 1 | N | 2026-01-01 | 45A Armthorpe Road Brampton Ontario CA L6T 5M4 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 07540195015012 | O-Two - Nitrile Powder Free Gloves | (905) 792-6896 | resuscitation@otwo.com |
| 07540195015029 | O-Two - Supply Hose Assembly | 9057926896 | resuscitation@otwo.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 9536 | 1941374087 | K991195 | CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATV | BTL | 1999-04-22 |
| 9536 | 1701128761 | K983705 | EMT RESUSCITATOR | BTL | 1998-10-29 |
| 9536 | 1814666605 | K960995 | CPR BIO-BARRIER FACESHEILD | CBP | 1997-01-07 |
| 9536 | 1769463352 | K940927 | RESCUE BREATHER | CBP | 1994-10-14 |
| 9536 | 1038217809 | K932170 | FLYNNR GENESIS II A/C, A/O AND IDLH | BTL | 1993-10-25 |
| 9536 | 1609935429 | K922810 | ODYSSEY | BTM | 1993-01-22 |
| 9536 | 1309416737 | K173205 | Equinox Advantage | BZR | 2018-08-29 |
| 9536 | 1637566444 | K170886 | HOMED Mesh Nebulizer | CAF | 2018-06-21 |
| 9536 | 1325044503 | K141595 | O-TWO E700,O-TWO E600,O-TWO E500 | BTL | 2015-03-16 |
| 9536 | 1598749980 | K121770 | HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER | CAF | 2013-04-17 |
| 9536 | 1135636892 | K113687 | EQUINOX RELIEVE | BZR | 2012-04-30 |
| 9536 | 1534523408 | K112546 | O_TWO CPAP SYSTEM | BYE | 2011-12-27 |
| 9536 | 1000235084 | K102377 | VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0 | CAP | 2010-11-18 |
| 9536 | 1431084615 | K093862 | CAREVENT HANDHELD CPAP SYSTEM | BTL | 2010-05-06 |
| 9536 | 2073162110 | K081330 | CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR) | BTL | 2009-03-06 |
| 9536 | 1725661074 | K070371 | FINGERTIP PULSE OXIMETER MD300C | DQA | 2007-08-13 |
| 9536 | 1847841436 | K051889 | CAREVENT CA AND DRA | BTL | 2005-08-30 |
| 9536 | 1695113570 | K051469 | CAREVENT ATV+ AND CAREVENT MRI | BTL | 2005-09-28 |
| 9536 | 1643652401 | K040841 | POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) | LZA | 2004-07-08 |
| 9536 | 1925909217 | K021328 | SMART BAG MO | BTM | 2003-06-26 |
| 9536 | 1707516674 | K002846 | HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR | BTM | 2001-06-06 |
| 9536 | 1000635660 | ||||
| 9536 | 1128477817 | ||||
| 9536 | 1187143917 | ||||
| 9536 | 1193848752 | ||||
| 9536 | 1249273971 | ||||
| 9536 | 1271288192 | ||||
| 9536 | 1500798194 | ||||
| 9536 | 1515764480 | ||||
| 9536 | 1608456173 | ||||
| 9536 | 1907042684 | ||||
| 9536 | 1969219685 | ||||
| 9536 | 2029944979 |
Product Codes Associated With Registrations#
PMN#
O-TWO E700,O-TWO E600,O-TWO E500
O-TWO MEDICAL TECHNOLOGIES, INC.
EQUINOX RELIEVE
O-TWO MEDICAL TECHNOLOGIES, INC.
O_TWO CPAP SYSTEM
O-TWO MEDICAL TECHNOLOGIES, INC.
CAREVENT HANDHELD CPAP SYSTEM
O-TWO MEDICAL TECHNOLOGIES, INC.
CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR)
O-TWO MEDICAL TECHNOLOGIES, INC.
CAREVENT ATV+ AND CAREVENT MRI
O-TWO MEDICAL TECHNOLOGIES, INC.
CAREVENT CA AND DRA
O-TWO MEDICAL TECHNOLOGIES, INC.
GUDID#
O-Two - Supply Hose Assembly
2023-11-07
O-Two - Supply Hose Assembly
2023-11-07
O Two - Demand Valve Resuscitator- FERNO O-Two Demand Valve Resuscitator comes standard with pressure relief system and audible alarm as well a manual ventilation button conveniently located on the front of the resuscitator. The manual ventilation flow rate is fixed at 40 L/min. During spontaneous respirations, the Demand valve resuscitator is designed to provide 100% oxygen to the patient with minimal inspiratory effort. The oxygen demand flow is controlled by the patient’s inspiratory effort with a minimum peak flow rate of 140 L/min to accommodate the patient’s own respiratory distress situation
2024-04-29
O Two - Demand Valve Resuscitator- FERNO O-Two Demand Valve Resuscitator comes standard with pressure relief system and audible alarm as well a manual ventilation button conveniently located on the front of the resuscitator. The manual ventilation flow rate is fixed at 40 L/min. During spontaneous respirations, the Demand valve resuscitator is designed to provide 100% oxygen to the patient with minimal inspiratory effort. The oxygen demand flow is controlled by the patient’s inspiratory effort with a minimum peak flow rate of 140 L/min to accommodate the patient’s own respiratory distress situation
2024-04-29
Pro Nox - The PRO NOX Relieve Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is a portable pneumatically powered device designed to provide a 50/50% nitrous oxide and oxygen mixture. It provides two input connectors for connection with nitrous oxide and oxygen cylinders through pressure regulators. The device has only one control for turning ON or OFF the device. When it is turned ON, the output of N2O/O2 gas mixture will only be activated by an inspiratory effort by the patient. The out put of N2O/O2 gas mixture is pre-set at 50/50%. Neither the patient nor medical personnel are able to adjust, eliminating the risk of delivering a hypoxic mixture.
2023-11-13
O-Two - Nitrile Powder Free Gloves
2023-11-07
O-Two - The O-Two Adjustable Oxygen Therapy Flow Controller is a calibrated, 12-position, fixed orifice, non-gravity sensitive flow controller. T
2023-11-07
O-Two - FLOW CONTROL 0-25 LPM O2 DISS. The O-Two Adjustable Oxygen Therapy Flow Controller is a calibrated, 12-position, fixed orifice, non-gravity sensitive flow controller.
2023-11-07
O-Two - O-Two Single-Use CPAP Nebulizer System c/w 6 L/min Flow Adapter, T-Piece, Updraft Nebulizer with Oxygen Supply Tubing
2023-06-22
O-Two - O-Two Single-Use CPAP Nebulizer System c/w 6 L/min Flow Adapter, T-Piece, Updraft Nebulizer with Oxygen Supply Tubing
2023-06-22
O-TWO - Oxygen Regulator- Pressure
2023-06-06
O-TWO - Oxygen Regulator
2023-06-06
O-TWO - Nitrous Oxide Regulator
2023-06-06
O-Two - 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 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.
2019-05-31
O-Two - 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 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.
2019-05-31
O-Two - 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.
2019-05-31
O-Two - The 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.
2019-05-31
O-Two - 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. The 01CV8010 is specifically designed for use on Bag-Valve-Mask resuscitators and ventilators without demand breathing or patient triggered ventilation modes.
2019-05-31
O-Two - The 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.
2019-10-31
O-Two - The 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.
2019-10-31
Fingertip Pulse Oximeter - Fingertip Pulse Oximeter is a portable non-invasive, spot-check, oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patient at home, and hospital (including clinical use and in internist/surgery, Anesthesia, intensive care and etc.). Not for continuously monitoring.
2016-09-23
Rescue Breather CPR Protective Barrier - The Rescue Breather consists of a one-way valve that has a large block is placed in a patient's mouth, The person providing CPR then blows through the valve to inflate patient's lung. The intended purpose of the valve and the filter is to prevent any cross contamination and potential cross infection by preventing contact with body fluids such as vomit, blood or saliva between patient and first aid provider. Each Rescue Breather is packed in a Royal Blue nylon keychain pouch.
2016-09-23
Rescue Breather CPR Protective barrier - The Rescue Breather consists of a one-way valve that has a large block is placed in a patient's mouth, The person providing CPR then blows through the valve to inflate patient's lung. The intended purpose of the valve and the filter is to prevent any cross contamination and potential cross infection by preventing contact with body fluids such as vomit, blood or saliva between patient and first aid provider. Each Rescue Breather is packed with a pair of gloves in a Red nylon keychain/belt pouch.
2016-09-23
Rescue Breather CPR Protective Barrier - The Rescue Breather consists of a one-way valve that has a large block is placed in a patient's mouth, The person providing CPR then blows through the valve to inflate patient's lung. The intended purpose of the valve and the filter is to prevent any cross contamination and potential cross infection by preventing contact with body fluids such as vomit, blood or saliva between patient and first aid provider. Each Rescue Breather is packed with a pair of gloves in a Royal Blue nylon keychain/belt pouch.
2016-09-23
CPR Bio-Barrier Training Faceshield - CPR Bio-Barrier Training Faceshield is intended to provide CPR trained individuals with personal protection from disease transmission during Expired Air Resuscitation (mouth to mouth) and during CPR training on manikins.The use if this device does not guarantee complete protection from disease transmission.
2016-02-03
Rescue Breather - The Rescue Breather consists of a one-way valve that has a large block is placed in a patient's mouth, The person providing CPR then blows through the valve to inflate patient's lung. The intended purpose of the valve and the filter is to prevent any cross contamination and potential cross infection by preventing contact with body fluids such as vomit, blood or saliva between patient and first aid provider.
2016-09-23
Rescue Breather CPR Protective Barrier - The Rescue Breather consists of a one-way valve that has a large block is placed in a patient's mouth, The person providing CPR then blows through the valve to inflate patient's lung. The intended purpose of the valve and the filter is to prevent any cross contamination and potential cross infection by preventing contact with body fluids such as vomit, blood or saliva between patient and first aid provider. Each Rescue Breather is packed in a BLACK nylon keychain pouch.
2016-09-23
Rescue Breather CPR Protective Barrier - The Rescue Breather consists of a one-way valve that has a large block is placed in a patient's mouth, The person providing CPR then blows through the valve to inflate patient's lung. The intended purpose of the valve and the filter is to prevent any cross contamination and potential cross infection by preventing contact with body fluids such as vomit, blood or saliva between patient and first aid provider. Each Rescue Breather is packed in a RED nylon keychain pouch.
2016-09-23
Rescue Breather CPR Protective Barrier - The Rescue Breather consists of a one-way valve that has a large block is placed in a patient's mouth, The person providing CPR then blows through the valve to inflate patient's lung. The intended purpose of the valve and the filter is to prevent any cross contamination and potential cross infection by preventing contact with body fluids such as vomit, blood or saliva between patient and first aid provider. Each Rescue Breather is packed in a Royal Blue nylon keychain pouch.
2016-09-23
Rescue Breather CPR Protective Barrier - The Rescue Breather consists of a one-way valve that has a large block is placed in a patient's mouth, The person providing CPR then blows through the valve to inflate patient's lung. The intended purpose of the valve and the filter is to prevent any cross contamination and potential cross infection by preventing contact with body fluids such as vomit, blood or saliva between patient and first aid provider. Each Rescue Breather is packed with a pair of gloves in a Black nylon keychain/belt pouch.
2016-09-23
Rescue Breather CPR Protective barrier - The Rescue Breather consists of a one-way valve that has a large block is placed in a patient's mouth, The person providing CPR then blows through the valve to inflate patient's lung. The intended purpose of the valve and the filter is to prevent any cross contamination and potential cross infection by preventing contact with body fluids such as vomit, blood or saliva between patient and first aid provider. Each Rescue Breather is packed with a pair of gloves in a Red nylon keychain/belt pouch.
2016-09-23
Rescue Breather CPR Protective Barrier - The Rescue Breather consists of a one-way valve that has a large block is placed in a patient's mouth, The person providing CPR then blows through the valve to inflate patient's lung. The intended purpose of the valve and the filter is to prevent any cross contamination and potential cross infection by preventing contact with body fluids such as vomit, blood or saliva between patient and first aid provider. Each Rescue Breather is packed with a pair of gloves in a Royal Blue nylon keychain/belt pouch.
2016-09-23
CPR Bio-Barrier Training Faceshield - CPR Bio-Barrier Training Faceshield is intended to provide CPR trained individuals with personal protection from disease transmission during Expired Air Resuscitation (mouth to mouth) and during CPR training on manikins. The use if this device does not guarantee complete protection from disease transmission.
2016-02-03
O-Two - 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 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.
2019-05-31
O-Two - 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 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.
2019-05-31
O-Two - 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.
2019-05-31
O-Two - The 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.
2019-05-31
O-Two - The 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.
2019-10-31
O-Two - The 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.
2019-10-31
O-Two - O-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.
2019-10-16