| Primary Device ID | 50190752159875 |
| NIH Device Record Key | a5f3e1a6-a9d9-42c7-bc13-d69f4c17cfea |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 3100B HFOV |
| Version Model Number | 29028-017 |
| Catalog Number | 29028-017 |
| Company DUNS | 080456871 |
| Company Name | VYAIRE MEDICAL, 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 50190752159875 [Primary] |
| LSZ | VENTILATOR, HIGH FREQUENCY |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-13 |
| Device Publish Date | 2021-05-05 |
| 10190752158993 | Flexible Patient Circuit w/Filter for 3100B (FP850) |
| 10190752158627 | 3100B VENT ASSY, DOMESTIC |
| 10190752155442 | 3100B VENT ASSY,220V/50HZ |
| 50190752159905 | Flexible Patient Circuit w/Filter for 3100B (HRCI) |
| 50190752159899 | Flexible Patient Circuit w/Filter for 3100B (FP850) |
| 50190752159882 | Flexible Patient Circuit w/Filter for 3100B (FP730) |
| 50190752159875 | 3100B Disposables Kit, Box of 4 / HRC |
| 50190752159868 | 3100B Disposables Kit, Box of 4 / F&P 850 |
| 50190752159851 | 3100B Disposables Kit, Box of 4 / F&P 730 |
| 50190752158915 | 3100B Disposables Kit, Box of 4 / HRC |
| 50190752157567 | 3100B Disposables Kit, Box of 4 / F&P 850 |
| 50190752155150 | 3100B Disposables Kit, Box of 4 / F&P 850 |
| 10190752158825 | 3100B Disposable Items Kit / F&P 850 |
| 10190752158818 | 3100B Disposable Items Kit / F&P 730 |
| 10190752158801 | 3100B Disposable Items Kit / HRCI |
| 50190752159004 | Flexible Patient Circuit w/Filter for 3100B (HRCI) |
| 50190752158984 | Flexible Patient Circuit w/Filter for 3100B (FP730) |