Primary Device ID | 07540195020269 |
NIH Device Record Key | a3917c31-d8a3-49d8-8967-0da55108d8f3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | O Two |
Version Model Number | 01DV2000-FER |
Company DUNS | 206449154 |
Company Name | O-Two Medical Technologies Inc |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | (905) 792-6896 |
resuscitation@otwo.c | |
Phone | (905) 792-6896 |
resuscitation@otwo.c | |
Phone | (905) 792-6896 |
resuscitation@otwo.c | |
Phone | (905) 792-6896 |
resuscitation@otwo.c | |
Phone | (905) 792-6896 |
resuscitation@otwo.c | |
Phone | (905) 792-6896 |
resuscitation@otwo.c | |
Phone | (905) 792-6896 |
resuscitation@otwo.c | |
Phone | (905) 792-6896 |
resuscitation@otwo.c | |
Phone | (905) 792-6896 |
resuscitation@otwo.c | |
Phone | (905) 792-6896 |
resuscitation@otwo.c | |
Phone | (905) 792-6896 |
resuscitation@otwo.c |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07540195020252 [Primary] |
GS1 | 07540195020269 [Package] Contains: 07540195020252 Package: chipBoxx [1 Units] In Commercial Distribution |
BTM | Ventilator, Emergency, Manual (Resuscitator) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-05-07 |
Device Publish Date | 2024-04-29 |
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 Nox | 2023-11-21 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 |