O Two

GUDID 07540195020269

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

O-Two Medical Technologies Inc

Demand valve
Primary Device ID07540195020269
NIH Device Record Keya3917c31-d8a3-49d8-8967-0da55108d8f3
Commercial Distribution StatusIn Commercial Distribution
Brand NameO Two
Version Model Number01DV2000-FER
Company DUNS206449154
Company NameO-Two Medical Technologies Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(905) 792-6896
Emailresuscitation@otwo.c
Phone(905) 792-6896
Emailresuscitation@otwo.c
Phone(905) 792-6896
Emailresuscitation@otwo.c
Phone(905) 792-6896
Emailresuscitation@otwo.c
Phone(905) 792-6896
Emailresuscitation@otwo.c
Phone(905) 792-6896
Emailresuscitation@otwo.c
Phone(905) 792-6896
Emailresuscitation@otwo.c
Phone(905) 792-6896
Emailresuscitation@otwo.c
Phone(905) 792-6896
Emailresuscitation@otwo.c
Phone(905) 792-6896
Emailresuscitation@otwo.c
Phone(905) 792-6896
Emailresuscitation@otwo.c

Device Identifiers

Device Issuing AgencyDevice ID
GS107540195020252 [Primary]
GS107540195020269 [Package]
Contains: 07540195020252
Package: chipBoxx [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTMVentilator, Emergency, Manual (Resuscitator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-07
Device Publish Date2024-04-29

Devices Manufactured by O-Two Medical Technologies Inc

07540195020269 - O Two 2024-05-07 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
07540195020269 - O Two 2024-05-07 Demand Valve Resuscitator- FERNO O-Two Demand Valve Resuscitator comes standard with pressure relief system and audible alarm a
17540195040073 - Pro Nox2023-11-21 The PRO NOX Relieve Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is a portable pneumatically powered device de
07540195015012 - O-Two 2023-11-15 Nitrile Powder Free Gloves
07540195015029 - O-Two 2023-11-15 Supply Hose Assembly
07540195015036 - O-Two 2023-11-15 Supply Hose Assembly
07540195050051 - O-Two 2023-11-15 The O-Two Adjustable Oxygen Therapy Flow Controller is a calibrated, 12-position, fixed orifice, non-gravity sensitive flow cont
07540195050075 - O-Two 2023-11-15 FLOW CONTROL 0-25 LPM O2 DISS. The O-Two Adjustable Oxygen Therapy Flow Controller is a calibrated, 12-position, fixed orifice,
17540195035154 - O-Two 2023-06-30 O-Two Single-Use CPAP Nebulizer System c/w 6 L/min Flow Adapter, T-Piece, Updraft Nebulizer with Oxygen Supply Tubing

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