| 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 |