| Primary Device ID | 00848530107598 |
| NIH Device Record Key | 488342b4-a4af-4e0a-82fe-3826d09061f7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CPAP Filters |
| Version Model Number | CF8006F-2PL |
| 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 | 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 | 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 | 00848530107598 [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 | 2025-11-20 |
| Device Publish Date | 2025-11-12 |
| 00848530107604 | 3B Luna and React G3X Replacement CPAP Filter - 6/Pack (in bags of 50) |
| 00848530107598 | Private Labeled" 3B Luna G3 and React G3X CPAP Reusable Filter - 2/Pack |