| Primary Device ID | 00850018761383 |
| NIH Device Record Key | 975ffdb9-bf1f-455d-807a-e602bfdf1fab |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VOCSN Passive Valve |
| Version Model Number | Passive Valve |
| Catalog Number | PRT-01450-000 |
| Company DUNS | 078758082 |
| Company Name | VENTEC LIFE SYSTEMS, 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 | true |
| Expiration Date | false |
| 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 | 00850018761383 [Primary] |
| GS1 | 00850018761390 [Package] Package: [10 Units] In Commercial Distribution |
| CBK | Ventilator, Continuous, Facility 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 | 2024-12-10 |
| Device Publish Date | 2024-12-02 |
| 00850018761413 - Internal Battery PM Upgrade USB Drive | 2025-08-14 Eaches- Internal Battery PM Upgrade USB Drive, PRT-01846-000 - 00850018761413 Packaged, Internal Battery PM Upgrade USB Drive (5 |
| 00850018761321 - Platinum® 10L Oxygen Concentrator | 2024-12-30 |
| 00850018761383 - VOCSN Passive Valve | 2024-12-10 |
| 00850018761383 - VOCSN Passive Valve | 2024-12-10 |
| 00850018761307 - HomeFill® Oxygen System | 2023-10-24 |
| 00850018761352 - HomeFill® Oxygen System | 2023-10-24 |
| 00850018761369 - HomeFill® Oxygen System | 2023-10-24 |
| 00850018761376 - HomeFill® Oxygen System | 2023-10-24 |
| 00855573007822 - VOCSN | 2023-07-10 |