| Primary Device ID | 00840106905461 |
| NIH Device Record Key | c9dbf2b6-0d0b-4a03-9b97-09c1ec341b69 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | O2asis Humidifier |
| Version Model Number | O2asis Humidifier Water Well |
| Company DUNS | 063142533 |
| Company Name | PERMA PURE LLC |
| 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 | 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 | 00810020360738 [Package] Package: Inner Pack [1 Units] In Commercial Distribution |
| GS1 | 00840106905461 [Primary] |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-15 |
| Device Publish Date | 2023-06-07 |
| 00810020360813 | O2asis Pediatric Cannula Consumable of O2asis Humidifier |
| 00840106905492 | O2asis Humidifier Kit |
| 10840106905475 | O2asis Humidifier Base Unit |
| 00840106905461 | O2asis Humidifier Water Well |
| 00810020360745 | O2asis Humidifier Water Pump |
| 00840106905447 | O2asis Cannula Adult Replacement consumable for the O2asis Humidifier |