| Primary Device ID | 00848530106461 |
| NIH Device Record Key | b058faaa-7d45-4337-b556-92cf58818520 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Peform Health PrecisionFit Full Face CPAP Mask - Mediom |
| Version Model Number | PH0301 |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| 00848530106966 - Tracheostomy and Suction Accessory | 2025-08-22 18fr Chimney, Straight Packed Catheter |
| 10848530106970 - Tracheostomy and Suction Accessory | 2025-08-22 6fr Chimney, Straight Packed Catheter - Delee |
| 10848530106987 - Tracheostomy and Suction Accessory | 2025-08-22 8fr Chimney, Straight Packed Catheter - Delee |
| 10848530106994 - Tracheostomy and Suction Accessory | 2025-08-22 10fr Directional, Straight Packed Catheter |
| 10848530107007 - Tracheostomy and Suction Accessory | 2025-08-22 12fr Directional, Straight Packed Catheter |
| 10848530107014 - Tracheostomy and Suction Accessory | 2025-08-22 8fr Directional, Straight Packed Catheter - Delee |
| 10848530107021 - Suction Kit | 2025-08-22 10fr Chimney Catheter, Gloves, Cup - KIT |
| 10848530107038 - Suction Kit | 2025-08-22 12fr Chimney Catheter, Gloves, Cup - KIT |