| Primary Device ID | 10709078012447 |
| NIH Device Record Key | bf871c42-d1bb-447b-840b-69da7f2bc0b9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aerosol Masks |
| Version Model Number | 220-E |
| Company DUNS | 092673953 |
| Company Name | WESTMED, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| 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 | 00709078012440 [Primary] |
| GS1 | 10709078012447 [Package] Contains: 00709078012440 Package: [50 Units] In Commercial Distribution |
| BYG | Mask, Oxygen |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-08 |
| Device Publish Date | 2021-05-31 |
| 10709078011426 | Pediatric Aerosol Mask w/ Vent Array |
| 10709078011419 | Adult Aerosol Mask w/ Vent Array |
| 10709078011402 | Aerosol Mask, Pediatric, Single Vents |
| 10709078012454 | Infant Aerosol Mask Single Vent |
| 10709078012447 | Aerosol Mask, Pediatric Elongated, Single Vents |