| Primary Device ID | 00848530106478 |
| NIH Device Record Key | c3e22b01-971a-492b-b085-8c86a712e334 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Peform Health PrecisionFit Full Face CPAP Mask- Large |
| Version Model Number | PH0302 |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| 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 |
| 00848530108298 - CPAP Filter | 2026-02-04 Filter, USA, Standard S9, AirSense 10, AirCurve, 2/pack |
| 00848530107932 - Nebulizer and Compressor | 2026-02-03 Sunset Compressor Nebulizer w/ Disposable Adult Neb Kit |
| 10848530108127 - Regulator | 2026-02-03 Standard CGA 870 Regulator, 1-DISS, 0-25LPM |
| 00848530108137 - CPAP Filter | 2026-02-03 Filter, USA, Airsense 11, Standard, 50/Pack |