| Primary Device ID | 07540261025853 |
| NIH Device Record Key | 76b7caaf-2bd3-42c5-8977-e3ba9f0709e0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | tremoflo C-100 Airwave Oscillometry System & Acces |
| Version Model Number | 102585 |
| Company DUNS | 257777701 |
| Company Name | Thorasys Thoracic Medical Systems 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| 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 | 5143848555 |
| techsupport@thorasys.com |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07540261025853 [Primary] |
| PNV | Impedance Measuring Device Utilizing Oscillation Techniques |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-08-20 |
| Device Publish Date | 2018-07-18 |
| 07540261025853 | Airwave Oscillometry System (ERT US Edition) compatible with ClearFlo PFT filter including power |
| 07540261015243 | Airwave Oscillometry System (US version) compatible with ClearFlo PFT filter including power sup |