| Primary Device ID | 07540195054219 | 
| NIH Device Record Key | 2a076ee9-704c-4f04-b27a-a1f2ad19d781 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | O-Two | 
| Version Model Number | 01OR6304 | 
| Catalog Number | 01OR6304 | 
| Company DUNS | 206449154 | 
| Company Name | O-Two Medical Technologies Inc | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| 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 | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Phone | 1-800-387-3405 | 
| cs@otwo.com | 
| Weight | 0.95 Kilogram | 
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 07540195054219 [Primary] | 
| CAX | Flowmeter, Tube, Thorpe, Back-Pressure Compensated | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2019-10-24 | 
| Device Publish Date | 2019-10-16 | 
| 17540195004518 | The Child Ventilation Timer is intended to guide the rescuer to provide ventilation at a rate ap | 
| 17540195004501 | The Adult Ventilation Timer is intended to guide the rescuer to provide ventilation at a rate ap | 
| 07540195054219 | The Multi Patient Unit is intended for delivery of adjustable oxygen therapy flow rates (0-15 L/ | 
| 17540195010359 | The Single-use cuff mask comes with an air cushion pad to provide comfort for the patient. It is | 
| 17540195010342 | The Single-use cuff mask comes with an air cushion pad to provide comfort for the patient. It is | 
| 17540195010335 | The Single-use cuff mask comes with an air cushion pad to provide comfort for the patient. It is | 
| 17540195010328 | The Single-use cuff mask comes with an air cushion pad to provide comfort for the patient. It is | 
| 07540195010314 | The Single-use cuff mask comes with an air cushion pad to provide comfort for the patient. It is | 
| 07540195010307 | The Single-use cuff mask comes with an air cushion pad to provide comfort for the patient. It is | 
| 17540195010151 | O-Two Resuscitation and Anesthesia Facemasks are intended to be used with automatic ventilator/m | 
| 17540195010144 | O-Two Resuscitation and Anesthesia Facemasks are intended to be used with automatic ventilator/m | 
| 07540195010130 | O-Two Resuscitation and Anesthesia Facemasks are intended to be used with automatic ventilator/m | 
| 17540195010120 | O-Two Resuscitation and Anesthesia Facemasks are intended to be used with automatic ventilator/m | 
| 17540195010113 | O-Two Resuscitation and Anesthesia Facemasks are intended to be used with automatic ventilator/m | 
| 17540195010106 | O-Two Resuscitation and Anesthesia Facemasks are intended to be used with automatic ventilator/m | 
| 17540195010038 | O-Two Resuscitation and Anesthesia Facemasks are intended to be used with automatic ventilator/m | 
| 07540195010024 | O-Two Resuscitation and Anesthesia Facemasks are intended to be used with automatic ventilator/m | 
| 17540195010014 | O-Two Resuscitation and Anesthesia Facemasks are intended to be used with automatic ventilator/m | 
| 07540195071322 | The Single-use Adult Nasal Cannula with Tubing is used to deliver supplemental oxygen to an adul | 
| 07540195071308 | The Single-use Adult Nasal Cannula is used to deliver supplemental oxygen to an adult patient i | 
| 07540195070219 | The Single-use Adult Medium Concentration Mask with Tubing is used to provide respiratory therap | 
| 07540195070202 | The Single-use Adult Medium Concentration Mask is used to provide respiratory therapy. It is ach | 
| 17540195005331 | The O-Two single-use electronic ventilator ventilation circuit consists of a single ventilation | 
| 17540195005218 | The O-Two single-use ventilation circuit is designed to be used with ventilators, demand valve o | 
| 17540195005188 | The O-Two single-use ventilation circuit is designed to be used with ventilators, demand valve o | 
| 17540195005171 | The O-Two single-use ventilation circuit is designed to be used with ventilators, demand valve o | 
| 07540195005129 | The O-Two single-use ventilation circuit is designed to be used with ventilators, demand valve o | 
| 07540195086616 | Nitrous Oxide Regulator | 
| 07540195060241 | Oxygen Regulator | 
| 07540195060111 | Oxygen Regulator- Pressure | 
| 17540195035154 | O-Two Single-Use CPAP Nebulizer System c/w 6 L/min Flow Adapter, T-Piece, Updraft Nebulizer with | 
| 07540195050075 | FLOW CONTROL 0-25 LPM O2 DISS. The O-Two Adjustable Oxygen Therapy Flow Controller is a calibrat | 
| 07540195050051 | The O-Two Adjustable Oxygen Therapy Flow Controller is a calibrated, 12-position, fixed orifice, | 
| 07540195015036 | Supply Hose Assembly | 
| 07540195015029 | Supply Hose Assembly | 
| 07540195015012 | Nitrile Powder Free Gloves | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  O-TWO  75550677  not registered Dead/Abandoned | O-Two Systems International Inc. 1998-09-10 | 
|  O-TWO  73723259  1525468 Dead/Cancelled | O-TWO SYSTEMS INTERNATIONAL INC. 1988-04-08 |