| 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 |
| 00848530089122 - Ventilator Kit | 2025-04-23 Adult Passive Heated Circuit, with Exhalation Port for Use with Philips Respironics Trilogy Comparable to OEM# 1076046, 1073227 |
| 00848530089375 - Suction Kit | 2025-04-23 Suction Kit This suction Kit contains: (1) RES023S, (1) RES024M, (1) RES025, and (1) TRAA001S |
| 00848530096861 - Oxygen Connector | 2025-04-23 Xmas Tree Connector - Non-Swivel - 10/pack |
| 00848530098728 - Mobility Support | 2025-04-23 BM001 StrongArm Comfort Cane This pack contains: (1) BM001, (1) BM001-TI, (1) BM001-BL |
| 00848530104429 - Oxygen Filter | 2025-04-23 Long Life Filter for Respironics EverFlo |
| 00848530104481 - CPAP Filter | 2025-04-23 Disposable Filter Comparable with LUISA Ventilator and Prisman CPAP |
| 00848530104597 - CPAP Filter | 2025-04-23 3B Luna G3 Reusable Filter - 6/Pack |
| 00848530104740 - CPAP Filter | 2025-04-23 Resprionics DreamStation 1 Disposable Filter - 2/Pack |