| Primary Device ID | 00848530082048 |
| NIH Device Record Key | f6e60632-b690-44b2-abef-7dc1a53f0867 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 3B Luna Style Ultrafine Filters |
| Version Model Number | CF8005 |
| Catalog Number | CF8005 |
| Company DUNS | 141668116 |
| Company Name | SUNSET HEALTHCARE SOLUTIONS, INC. |
| Device Count | 12 |
| 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 | 00848530082048 [Primary] |
| GS1 | 10848530082045 [Unit of Use] |
| 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 | 2018-07-05 |
| Device Publish Date | 2018-06-04 |
| 10848530108189 - Repair Parts | 2026-03-17 Inogen G3 Filter Cage Replacement (OEM: RP-301) - 2/PK |
| 10848530108196 - Repair Parts | 2026-03-17 Inogen G5 Filter Cage Replacement (OEM: RP-500) -2/PK |
| 10848530108202 - Oxygen, Bacteria & HEPA Filter | 2026-03-17 Inogen G2/G3 Output Filter (OEM: RP-101) - 10/PK |
| 10848530108219 - Oxygen, Bacteria & HEPA Filter | 2026-03-17 Inogen G4/G5 Output Filter (OEM: RP-410) - 10/PK |
| 00848530108571 - Repair Parts | 2026-03-17 Labels for the RP036 Shround, PerfectO2, Black - BULK |
| 00848530108588 - Repair Parts | 2026-03-17 Labels for the RP036 Shround, PerfectO2 V, Blue - BULK |
| 10848530108356 - Vented CPAP Masks | 2026-03-11 Sunset Adult Dual Limb Active Circuit |
| 10848530108363 - Vented CPAP Masks | 2026-03-11 Sunset Peditric Dual Limb Active Circuit |