| Primary Device ID | 10709078000390 |
| NIH Device Record Key | 67765585-c5bd-4342-b704-57f0fc0fe9ff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VixOne |
| Version Model Number | 0209 |
| Company DUNS | 092673953 |
| Company Name | WESTMED, 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 | 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00709078000393 [Primary] |
| GS1 | 10709078000390 [Package] Contains: 00709078000393 Package: [50 Units] In Commercial Distribution |
| CAF | Nebulizer (Direct Patient Interface) |
| 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 | 2016-11-24 |
| 00709078002359 | VixOne Nebulizer Bulk(325/Cs) |
| 10709078002332 | VixOne, Infant Nebulizer Kit |
| 10709078002325 | VixOne Infant Inline Nebulizer Kit W/15mm Tee |
| 10709078001687 | Nebulizer Composite Kit |
| 10709078000499 | Small Volume Nebulizer |
| 10709078000482 | Small Volume Nebulizer |
| 10709078000475 | Small Volume Nebulizer |
| 10709078000468 | Small Volume Nebulizer |
| 10709078000451 | Small Volume Nebulizer |
| 10709078000444 | Small Volume Nebulizer |
| 10709078000437 | Small Volume Nebulizer |
| 10709078000420 | Small Volume Nebulizer |
| 10709078000413 | Small Volume Nebulizer |
| 10709078000406 | Small Volume Nebulizer |
| 10709078000390 | Small Volume Nebulizer |