| Primary Device ID | 00848530108427 |
| NIH Device Record Key | e34ec282-8a29-4eb3-9464-8595fcc530a7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ventilator Filter |
| Version Model Number | VF005-1 |
| Company DUNS | 141668116 |
| Company Name | SUNSET HEALTHCARE SOLUTIONS, 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 | false |
| 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 |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00848530108427 [Primary] |
| JRL | Unit, Filter, Membrane |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-02 |
| Device Publish Date | 2026-02-20 |
| 00848530105952 | Ventec VOCSN Style Fan Filter - 750pcs |
| 00848530105945 | Ventec VOCSN Patient Air Intake Filter - 750pcs |
| 00848530104498 | Resusable Filter Compatible with LUISA Ventilator and prisma CPAP |
| 00848530108427 | Sunset Particulate Filter for Respironics Trilogy Ventilator (OEM# 1134430) – 1/PK |