NIOX 12-1700
GUDID 07350047030298
The NO sensor for NIOX VERO utilizes analytical electrochemical sensor technology. The NO sensor is pre-programmable for a defined number of tests: 60
Circassia AB
Nitrogen monoxide analyser Nitrogen monoxide analyser Nitrogen monoxide analyser Nitrogen monoxide analyser Nitrogen monoxide analyser Nitrogen monoxide analyser Nitrogen monoxide analyser Nitrogen monoxide analyser Nitrogen monoxide analyser Nitrogen monoxide analyser Nitrogen monoxide analyser Nitrogen monoxide analyser Nitrogen monoxide analyser Nitrogen monoxide analyser Nitrogen monoxide analyser| Primary Device ID | 07350047030298 |
| NIH Device Record Key | 110f9763-1c8b-418b-b0cc-c5bb5326002d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NIOX |
| Version Model Number | VERO Sensor 1000 |
| Catalog Number | 12-1700 |
| Company DUNS | 632700860 |
| Company Name | Circassia AB |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1 (866) 275-6469 |
| Regulatory@circassia.com | |
| Phone | 1 (866) 275-6469 |
| Regulatory@circassia.com | |
| Phone | 1 (866) 275-6469 |
| Regulatory@circassia.com | |
| Phone | 1 (866) 275-6469 |
| Regulatory@circassia.com | |
| Phone | 1 (866) 275-6469 |
| Regulatory@circassia.com | |
| Phone | 1 (866) 275-6469 |
| Regulatory@circassia.com | |
| Phone | 1 (866) 275-6469 |
| Regulatory@circassia.com | |
| Phone | 1 (866) 275-6469 |
| Regulatory@circassia.com | |
| Phone | 1 (866) 275-6469 |
| Regulatory@circassia.com | |
| Phone | 1 (866) 275-6469 |
| Regulatory@circassia.com | |
| Phone | 1 (866) 275-6469 |
| Regulatory@circassia.com | |
| Phone | 1 (866) 275-6469 |
| Regulatory@circassia.com | |
| Phone | 1 (866) 275-6469 |
| Regulatory@circassia.com | |
| Phone | 1 (866) 275-6469 |
| Regulatory@circassia.com | |
| Phone | 1 (866) 275-6469 |
| Regulatory@circassia.com |
Operating and Storage Conditions
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 99 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 99 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 99 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 99 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 99 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 99 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 99 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 99 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 99 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 99 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 99 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 99 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 99 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 99 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 99 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07350047030298 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K133898
FDA Product Code
| MXA | System,Test,Breath Nitric Oxide |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-02-14 |
| Device Publish Date | 2016-09-21 |
On-Brand Devices [NIOX]
| 07350047030519 | NIOX Apps / Panel is an optional software accessory allowing an additional display for the NIOX |
| 07350047030496 | Disposable patient filter for use with the NIOX VERO device to be changed for each new measureme |
| 07350047030472 | NIOX VERO® measures Nitric Oxide (NO) in human breath. Nitric Oxide is frequently increased in |
| 07350047030038 | Disposable filter (NIOX Filter) to be changed for each new measurement session and for each new |
| 07350047030175 | The NIOX VERO is supplied with an exchangeable handle accessory, to which the patient filter is |
| 07350047030106 | The NO sensor for NIOX MINO utilizes analytical electrochemical sensor technology. The NO sensor |
| 07350047030120 | NIOX MINO measures Nitric Oxide (NO) in human breath. Nitric Oxide is frequently increased in so |
| 07350047030380 | The NO sensor for NIOX VERO utilizes analytical electrochemical sensor technology. The NO sensor |
| 07350047030366 | This is a rechargeable Li-Ion replacement battery for the NIOX VERO that is charged via the powe |
| 07350047030298 | The NO sensor for NIOX VERO utilizes analytical electrochemical sensor technology. The NO sensor |
| 07350047030281 | The NO sensor for NIOX VERO utilizes analytical electrochemical sensor technology. The NO sensor |
| 07350047030274 | The NO sensor for NIOX VERO utilizes analytical electrochemical sensor technology. The NO sensor |
| 07350047030267 | The NO sensor for NIOX VERO utilizes analytical electrochemical sensor technology. The NO sensor |
| 07350047030168 | The NO sensor for NIOX MINO utilizes analytical electrochemical sensor technology. The NO sensor |
| 07350047030113 | The NO Scrubber for the NIOX MINO device eliminates ambient NO that is inhaled by the patient, a |
| 07350047030076 | The NO sensor for NIOX MINO utilizes analytical electrochemical sensor technology. The NO sensor |
| 07350047030069 | The NO sensor for NIOX MINO utilizes analytical electrochemical sensor technology. The NO sensor |
| 07350047030052 | The NO sensor for NIOX MINO utilizes analytical electrochemical sensor technology. The NO sensor |
| 07350047030717 | Contains one sensor preprogrammed for a defined number of tests that is placed in the NIOX VERO |
| 07350047030700 | Contains one sensor preprogrammed for a defined number of tests that is placed in the NIOX VERO |
| 07350047030694 | Contains one sensor preprogrammed for a defined number of tests that is placed in the NIOX VERO |
| 07350047030687 | Contains one sensor preprogrammed for a defined number of tests that is placed in the NIOX VERO |
| 07350047030670 | Contains One NIOX VERO device, one sensor pre-programmed for a defined number of tests that is p |
| 07350047030663 | Contains One NIOX VERO device, one sensor pre-programmed for a defined number of tests that is p |
Trademark Results [NIOX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NIOX 79100293 4204066 Live/Registered |
Circassia AB 2011-06-13 |
 NIOX 78718103 3473753 Dead/Cancelled |
The Gillette Company 2005-09-22 |
 NIOX 76171275 3303027 Dead/Cancelled |
Aerocrine AB 2000-11-27 |
 NIOX 76061035 not registered Dead/Abandoned |
Aerocrine AB 2000-06-01 |
 NIOX 75982202 2595291 Live/Registered |
Aerocrine AB 2000-06-01 |
 NIOX 72101171 0739347 Dead/Expired |
CAL HASS 1960-07-20 |
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