| Primary Device ID | 10848530040007 |
| NIH Device Record Key | 49c20fcc-e056-4e0f-a6c2-cae3dd7a6695 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Classic Full Face CPAP Mask with Headgear - Large |
| Version Model Number | CM007L |
| Catalog Number | CM007L |
| Company DUNS | 141668116 |
| Company Name | SUNSET HEALTHCARE SOLUTIONS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| 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 |
| Phone | 877-578-6738 |
| customerservice@sunsethcs.com |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00848530040000 [Primary] |
| GS1 | 10848530040007 [Package] Contains: 00848530040000 Package: Corrugated Box [50 Units] In Commercial Distribution |
| BZD | Ventilator, Non-Continuous (Respirator) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
| 00848530001773 - Oxygen Kit | 2024-07-04 Oxygen Kit |
| 00848530001780 - Oxygen Kit | 2024-07-04 Oxygen Kit |
| 00848530003241 - Oxygen Kit | 2024-07-04 Oxygen Kit |
| 00848530003388 - Oxygen Kit | 2024-07-04 Oxygen Kit |
| 00848530003517 - Oxygen Kit | 2024-07-04 Oxygen Kit |
| 00848530060817 - Oxygen Kit | 2024-07-04 Oxygen Kit |
| 00848530061852 - Oxygen Kit | 2024-07-04 Oxygen Kit |
| 00848530081805 - Oxygen Kit | 2024-07-04 Oxygen Kit |