| Primary Device ID | 95060541640132 |
| NIH Device Record Key | b753423c-3e7b-4b1c-bba4-b9970d84867d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NOxBOXi |
| Version Model Number | FIL064 |
| Catalog Number | NXBFIL064 |
| Company DUNS | 220841986 |
| Company Name | NOXBOX LTD |
| Device Count | 50 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| 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 | 1-833-669-8368 |
| NoxiventUS@Praxair.com | |
| Phone | 1-833-669-8368 |
| NoxiventUS@Praxair.com |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 800 millibar and 1200 millibar |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 800 millibar and 1200 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 800 millibar and 1200 millibar |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 800 millibar and 1200 millibar |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060541640139 [Unit of Use] |
| GS1 | 15060541640136 [Primary] |
| GS1 | 95060541640132 [Package] Contains: 15060541640136 Package: BOX [999999999 Units] In Commercial Distribution |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-12-06 |
| Device Publish Date | 2018-11-05 |
| 05060541640191 | Calibration Gas NO2 |
| 05060541640184 | Calibration gas NO |
| 25060541640089 | Single use connections kit for Bunnell Jet ventilator |
| 25060541640072 | System Test kit |
| 25060541640065 | Single use 12mm size 2 delivery and sampling kit |
| 25060541640058 | Single use 10mm delivery and sampling kit |
| 25060541640041 | Single use 15mm size 2 delivery and sampling kit |
| 25060541640034 | Single use 22mm size 2 delivery and sampling kit |
| 05060541640023 | Nitric Oxide Delivery and Monitoring System - Head unit and Trolley |
| 05060541640016 | Nitric Oxide Delivery and Monitoring System - Head Unit Only |
| 15060541640167 | Single use tubing for connection between NOxMixer and NOxFLOW during back up mode |
| 95060541640149 | Single use connector 22M/15F-15M Gas Sampling Port |
| 95060541640132 | Single use 50mm Nebuliser filter |
| 95060541640125 | Single use 25mm Disk Filter for water trap |
| 95060541640118 | Single use 22mm one-way valve for use with Sensor Medics 3100A/B HFO ventilators |