| Primary Device ID | 00848530051228 |
| NIH Device Record Key | 898c5969-361d-4d12-89e1-384c126997da |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 492 Kit |
| Version Model Number | OF6002SP |
| Catalog Number | OF6002SP |
| 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 | true |
| 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 | 877-578-6738 |
| customerservice@sunsethcs.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00848530051228 [Primary] |
| JRL | Unit, Filter, Membrane |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-08-31 |
| Device Publish Date | 2018-07-31 |
| 00848530040291 - Oxygen Masks | 2024-08-23 Sunset Breathing Mask, No Hook s - Adult Small |
| 00848530040307 - Oxygen Masks | 2024-08-23 Sunset Breathing Mask, No Hooks - Adult Medium |
| 00848530040314 - Oxygen Masks | 2024-08-23 Sunset Breathing Mask, No Hooks - Adult Large |
| 00848530104214 - Oxygen Masks | 2024-08-23 Sunset Breathing Mask, No Hooks - Infant |
| 00848530104221 - Oxygen Masks | 2024-08-23 Sunset Breathing Mask, No Hooks - Toddler |
| 10848530091290 - Power and Accessories | 2024-08-16 Portable Suction Machine DC Mobile Power Adapter |
| 00848530091378 - Portable Suction | 2024-08-16 Portable Suction Machine AC |
| 10848530091870 - Power and Accessories | 2024-08-16 Replacement Battery for SU100DC Portable Suction Machine |