| Primary Device ID | 00860009312234 |
| NIH Device Record Key | d8caf852-97ff-487d-9672-361bc15c0fc8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bonhawa Air Filter |
| Version Model Number | AF |
| Company DUNS | 117854209 |
| Company Name | Telesair, 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860009312234 [Primary] |
| GS1 | 10860009312231 [Package] Package: Case [30 Units] In Commercial Distribution |
| GS1 | 20860009312238 [Package] Package: Inner Pack [3 Units] In Commercial Distribution |
| 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 | 2025-03-24 |
| Device Publish Date | 2025-03-14 |
| 00860009312234 - Bonhawa Air Filter | 2025-03-24 |
| 00860009312234 - Bonhawa Air Filter | 2025-03-24 |
| 00850057298000 - Bonhawa Respiratory Humidifier | 2025-03-20 |
| 10860009312262 - Adult Nasal Cannula, Small | 2025-03-20 |
| 10860009312279 - Adult Nasal Cannula, Medium | 2025-03-20 |
| 10860009312286 - Adult Nasal Cannula, Large | 2025-03-20 |
| 00860009312296 - Heated Breathing Set | 2025-03-20 Contains: (1) Breathing Circuit (1) Water Chamber (1) Water Chamber Adaptor |