| Primary Device ID | 10841470104440 |
| NIH Device Record Key | d6d0c308-4f83-4ff8-b65d-f013f4f2936d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BiTrac SE Select |
| Version Model Number | 313-9506 |
| Company DUNS | 030619483 |
| Company Name | PULMODYNE 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |