| Primary Device ID | 10709078014090 |
| NIH Device Record Key | d95ed6ac-a90c-4bde-8587-87c8d6817ab6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bubble Humidifier |
| Version Model Number | 1002283 |
| 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 | false |
| Serial Number | true |
| 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 | 00709078014093 [Primary] |
| GS1 | 10709078014090 [Package] Contains: 00709078014093 Package: [25 Units] In Commercial Distribution |
| KFZ | Humidifier, Non-Direct Patient Interface (Home-Use) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-04-08 |
| Device Publish Date | 2022-03-31 |
| 00709078003158 | Bubble Humidifier, Dry, High Flow |
| 10709078007603 | Bubble Humidifier, Dry |
| 10709078014281 | Concentrator Bubble Humidifier Elbow Adaptor |
| 10709078014274 | DRY BUBBLE HUMIDIFIER LOW FLOW Up To 6 LPM |
| 10709078014090 | DRY BUBBLE HUMIDIFIER HIGH FLOW 6 - 20 LPM |