| Primary Device ID | 10841470107021 |
| NIH Device Record Key | 33c25375-5e7d-4d66-be0c-bf151bce706b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BiTrac Shield |
| Version Model Number | 313-9050W |
| 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 |
| Phone | 317-246-5505 |
| info@pulmodyne.com |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00084147107024 [Primary] |
| GS1 | 00841470107024 [Primary] |
| GS1 | 10841470107021 [Package] Contains: 00841470107024 Package: [10 Units] In Commercial Distribution |
| BZD | Ventilator, Non-Continuous (Respirator) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-10-30 |
| Device Publish Date | 2016-10-07 |
| 10841470105454 - HMEF | 2024-07-09 |
| 10841470105461 - HMEF | 2024-07-09 |
| 10841470105478 - HMEF | 2024-07-09 |
| 10841470105485 - HMEF | 2024-07-09 |
| 10841470100718 - VT Select | 2023-04-18 |
| 10841470100749 - VT Select | 2023-04-18 |
| 10841470100770 - VT Select | 2023-04-18 |
| 10841470100794 - VT Select | 2023-04-18 |