| Primary Device ID | 07540195033030 |
| NIH Device Record Key | ddcc813f-47f9-44b8-8ffc-74e4d31abdd0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | o_two e600 |
| Version Model Number | 01EVE600 |
| Catalog Number | 01EVE600 |
| 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 | false |
| 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 | 2.4 Kilogram |
| Height | 155 Millimeter |
| Width | 200 Millimeter |
| Length | 250 Millimeter |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07540195033023 [Direct Marking] |
| GS1 | 07540195033030 [Primary] |
| BTL | Ventilator, Emergency, Powered (Resuscitator) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-23 |
| 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 |