| Primary Device ID | 10709078004954 |
| NIH Device Record Key | e1a88443-c5a4-49e5-9a0e-4055a577a60c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VixOne Nebulizer |
| Version Model Number | 0327 |
| 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 | 00709078004957 [Primary] |
| GS1 | 10709078004954 [Package] Contains: 00709078004957 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 | 2017-10-20 |
| 10709078006194 | VixOne Nebulizer 7' Tubing |
| 10709078004961 | VixOne Nebulizer w/ Pediatric Elongated Mask |
| 10709078004954 | VixOne Nebulizer w/ Adult Elongated Mask |
| 00709078001574 | Bulk packaged |
| 00709078000676 | Bulk Packaged |