| Primary Device ID | 00848530051198 |
| NIH Device Record Key | 45385061-cf37-477b-b079-f95e53959a04 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Breeze Quiet One Kit |
| Version Model Number | OF11001SP |
| Catalog Number | OF11001SP |
| 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 | true |
| 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 | 00848530051198 [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 | 2018-08-31 |
| Device Publish Date | 2018-07-31 |
| 00848530107642 - CPAP Filter | 2025-12-02 Private Labeled 3B Luna G3 and React G3X CPAP Reusable Filter - 2/Pack (pack of 20) |
| 00848530107659 - Repair Part | 2025-12-02 Lip Seal for Helios - Metal |
| 00848530107666 - Repair Parts | 2025-12-02 Lip Seal for Helios - Rubber |
| 00848530107673 - Repair Parts | 2025-12-02 41 Contents Gauge Rebuilt |
| 00848530107680 - Repair Parts | 2025-12-02 Tube Fill for C1000/C1000T |
| 00848530107697 - Repair Parts | 2025-12-02 Assembly Indicator Weight for C1000/C1000T |
| 00848530107703 - Repair Parts | 2025-12-02 Quick Connect Adapter for C1000/C1000T |
| 00848530107710 - Repair Parts | 2025-12-02 Warming Coil for C1000 |