| Primary Device ID | 00848530099374 |
| NIH Device Record Key | b82bdd6c-8a5c-4205-81c2-88c0512ff1fb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CPAP Mask |
| Version Model Number | CUCM061L |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| 00848530097066 | Adult Aerosol Mask |
| 00848530098315 | Full Face CPAP Mask with Clips Small - No Elbow or HG |
| 00848530098308 | Full Face CPAP Mask with Clips Medium - No Elbow or HG |
| 00848530098292 | Full Face CPAP Mask with Clips Large - No Elbow or HG |
| 00848530098049 | Novaplus Full Face Mask, Standard Elbow, with Standard Headgear, Large-each |
| 00848530098032 | Novaplus Full Face Mask, Standard Elbow, with Standard Headgear, Medium-each |
| 00848530098025 | Novaplus Full Face Mask, Standard Elbow, with Standard Headgear, Small-each |
| 00848530098018 | Novaplus Full Face Mask, Single Limb Elbow Vented, with Standard Headgear, Large-each |
| 00848530098001 | Novaplus Full Face Mask, Single Limb Elbow Vented, with Standard Headgear, Medium-each |
| 00848530097998 | Novaplus Full Face Mask, Single Limb Elbow Vented, with Standard H |
| 00848530097981 | Novaplus Full Face Mask, Single Limb Elbow, with Standard Headgear, Large-each |
| 00848530097974 | VCM041MEE-1 |
| 00848530097967 | Novaplus Full Face Mask, Single Limb Elbow, with Standard Headgear, Small-each |
| 00848530088941 | Nasal CPAP Mask — Small |
| 00848530097493 | Novaplus Nasal Mask with Standard Headgear, Large |
| 00848530097486 | Novaplus Nasal Mask with Standard Headgear, Medium |
| 00848530097479 | Novaplus Nasal Mask with Standard Headgear, Small |
| 00848530099473 | Pediatric Full Face CPAP Mask Headgear – Small |
| 00848530099459 | Pediatric Full Face CPAP Mask Headgear – Large |
| 00848530099435 | Pediatric Full Face CPAP Mask Cushion Replacement – XL |
| 00848530099411 | Pediatric Full Face CPAP Mask Cushion Replacement – Small |
| 00848530099398 | Pediatric Full Face CPAP Mask Cushion Replacement – Medium |
| 00848530099374 | Pediatric Full Face CPAP Mask Cushion Replacement – Large |
| 00848530099350 | Pediatric Full Face CPAP Mask - XL |
| 00848530099336 | Pediatric Full Face CPAP Mask - Small |
| 00848530099312 | Pediatric Full Face CPAP Mask - Medium |
| 00848530099299 | Pediatric Full Face CPAP Mask - Large |
| 10848530090668 | Sunset Clearsight Deluxe Nasal CPAP - Small |
| 00848530097172 | Full Face Mask, Single Limb Elbow, with Cap Style Headgear, Large |