| Primary Device ID | 00848530097608 |
| NIH Device Record Key | 88300ec3-d706-4c24-9308-5d862a6b44b5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CPAP Mask Cushion |
| Version Model Number | CUCM205S |
| 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 | 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 | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00848530097608 [Primary] |
| BZD | Ventilator, Non-Continuous (Respirator) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-23 |
| Device Publish Date | 2024-07-15 |
| 00848530091095 | Deluxe Full Face Mask Replacement Cushion — Large |
| 00848530091088 | Deluxe Full Face Mask Replacement Cushion — Medium |
| 00848530091064 | Deluxe Nasal Mask Replacement Cushion — Large |
| 00848530091057 | Deluxe Full Face Mask Replacement Cushion — Medium |
| 00848530091040 | Deluxe Full Face Mask Replacement Cushion — Small |
| 00848530090654 | Clearsight Deluxe Nasal Mask Replacement Cushion — Large |
| 00848530090647 | Clearsight Deluxe Nasal Mask Replacement Cushion — Medium |
| 00848530090630 | Clearsight Deluxe Nasal Mask Replacement Cushion — Small |
| 00848530085223 | Deluxe Nasal Mask Replacement Cushion - Small |
| 00848530097608 | Replacement Cushion for Sunset Sol Full Face CPAP Mask - Small |
| 00848530097585 | Replacement Cushion for Sunset Sol Full Face CPAP Mask - Large |