| Primary Device ID | 17540195040073 |
| NIH Device Record Key | 6b5e7705-0b07-4e2b-9a8f-a1682b3387d9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pro Nox |
| Version Model Number | CMI-0100-PNX |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 9057926896 |
| resuscitation@OTWO.COM | |
| Phone | 9057926896 |
| resuscitation@OTWO.COM | |
| Phone | 9057926896 |
| resuscitation@OTWO.COM | |
| Phone | 9057926896 |
| resuscitation@OTWO.COM | |
| Phone | 9057926896 |
| resuscitation@OTWO.COM | |
| Phone | 9057926896 |
| resuscitation@OTWO.COM | |
| Phone | 9057926896 |
| resuscitation@OTWO.COM | |
| Phone | 9057926896 |
| resuscitation@OTWO.COM | |
| Phone | 9057926896 |
| resuscitation@OTWO.COM | |
| Phone | 9057926896 |
| resuscitation@OTWO.COM | |
| Phone | 9057926896 |
| resuscitation@OTWO.COM | |
| Phone | 9057926896 |
| resuscitation@OTWO.COM | |
| Phone | 9057926896 |
| resuscitation@OTWO.COM | |
| Phone | 9057926896 |
| resuscitation@OTWO.COM | |
| Phone | 9057926896 |
| resuscitation@OTWO.COM | |
| Phone | 9057926896 |
| resuscitation@OTWO.COM | |
| Phone | 9057926896 |
| resuscitation@OTWO.COM | |
| Phone | 9057926896 |
| resuscitation@OTWO.COM |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07540195040076 [Direct Marking] |
| GS1 | 17540195040073 [Primary] |
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-21 |
| Device Publish Date | 2023-11-13 |
| 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 | 2023-11-21The 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. |
| 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 |