| Primary Device ID | 00084853000905 |
| NIH Device Record Key | 9819c8fe-51ad-48d1-9a9b-cc27b513c546 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Oxygen, Bacteria & HEPA Filter |
| Version Model Number | AMED014BF1412-3 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00084853000905 [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 | 2025-06-26 |
| Device Publish Date | 2025-06-18 |
| 00848530108434 - Oxygen Kit | 2026-02-26 Oxygen Kit (6- RES1107S, 1- RES3050G,2- RES012, 2 -RES001) |
| 00848530108311 - Oxygen Kit | 2026-02-19 10L Oxygen Supply Kit 4 RES1107SHF High Flow Soft Cannula with 7ft Supply Tube 2 RES003 No Smoking Sign 2 RES3025G Oxygen Suppl |
| 00848530108335 - Repair Parts | 2026-02-19 CAIRE Contents Gauge Tubing (OEM# B-775856-SV) - 2/PK |
| 00848530108342 - Repair Parts | 2026-02-19 C1000/C1000T Portable Rubber Foot - 56/Sheet - 10 Sheet/Case - (OEM# B-775010-00) |
| 00848530108168 - Regulators | 2026-02-10 Private Labeled - Standard CGA 870 Regulator, 1-DISS, 0-25LPM |
| 10848530108172 - CPAP Accessory | 2026-02-10 Sunset Nasal Gel Pad - 5/PK |
| 00848530108267 - Filter - Vent | 2026-02-10 Luisa Gross Particle Internal Filter - 1/PK |
| 10848530108271 - CPAP Tubing | 2026-02-10 Adapter for Resmed S10 Heated CPAP Tube System |