| Primary Device ID | 00848530086480 |
| NIH Device Record Key | 3b9a9b81-cf12-4ed4-9f98-f1082266adaa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Plastic Intake Nebulizer Filters |
| Version Model Number | BF026S |
| Catalog Number | BF026S |
| Company DUNS | 141668116 |
| Company Name | SUNSET HEALTHCARE SOLUTIONS, INC. |
| Device Count | 10 |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| Phone | 877-578-6738 |
| customerservice@sunsethcs.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00848530086480 [Primary] |
| GS1 | 10848530086487 [Unit of Use] |
| JRL | Unit, Filter, Membrane |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-08-17 |
| Device Publish Date | 2018-06-29 |
| 00848530107949 - CPAP Filter | 2025-12-25 Private Labeled"Respironics DreamStation Reusable Filter - 1/PK |
| 00848530107956 - CPAP Filter | 2025-12-25 Private Labeled" Respironics Dream Station 2 Reusable Filter - 1/PK |
| 00848530107963 - CPAP Filter | 2025-12-25 Private Labeled"Resmed S9 & S10 CPAP Filter - 50/PK |
| 00848530107970 - CPAP Filter | 2025-12-25 Private Labeled"Resmed AirMini CPAP Filter - 2/PK |
| 00848530107987 - CPAP Filter | 2025-12-25 Private Labeled"Resmed AirMini CPAP Filter - 12/PK |
| 00848530107994 - CPAP Filter | 2025-12-25 Private Labeled"Resmed Airsense 11 CPAP Filter - 50/PK |
| 10848530108103 - Filter - Vent | 2025-12-25 Sunset Particle Filter for Respironics Trilogy Ventilator – 10/PK |
| 10848530108004 - Repair Parts | 2025-12-22 Stratus Power Cord - EA |