Address:45A Armthorpe Road,Brampton Ontario,CA
Device Description : O-Two Resuscitation and Anesthesia Facemasks are intended to be used with automa 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 Silicone facemasks are ideal for anesthesia as they withstand repeated autoclaving. The Infant Silicone Face Mask 02FM5101 fits infant patients.
Device Class : 1
Duns Number: 206449154
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : O-Two Resuscitation and Anesthesia Facemasks are intended to be used with automa 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 Silicone facemasks are ideal for anesthesia as they withstand repeated autoclaving. The Neonate Silicone Face Mask 02FM5102 fits neonate patients.
Device Class : 1
Duns Number: 206449154
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The Single-use cuff mask comes with an air cushion pad to provide comfort for th The 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.
Device Class :
Duns Number: 206449154
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The Single-use cuff mask comes with an air cushion pad to provide comfort for th The 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.
Device Class :
Duns Number: 206449154
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The Single-use cuff mask comes with an air cushion pad to provide comfort for th The 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.
Device Class : 1
Duns Number: 206449154
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The Single-use cuff mask comes with an air cushion pad to provide comfort for th The 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.
Device Class : 1
Duns Number: 206449154
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The Single-use cuff mask comes with an air cushion pad to provide comfort for th The 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.
Device Class : 1
Duns Number: 206449154
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The Single-use cuff mask comes with an air cushion pad to provide comfort for th The 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.
Device Class : 1
Duns Number: 206449154
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : O-Two Demand Valve Resuscitator comes standard with pressure relief system and a 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 aminimum peak flow rate of 140 L/min to accommodate the patient’s own respiratory distress situation.
Device Class : 2
Duns Number: 206449154
Premarket Exempt : No
Prescription Use : Yes
Device Description : O-Two Demand Valve Resuscitator Kit contains a Demand Valve resuscitator and a p O-Two Demand Valve Resuscitator Kit contains a Demand Valve resuscitator and a pressure regulator.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 aminimum peak flow rate of 140 L/min to accommodate the patient’s own respiratory distress situation.
Device Class :
Duns Number: 206449154
Premarket Exempt : No
Prescription Use : Yes