| Primary Device ID | 10848530103696 |
| NIH Device Record Key | edc8dbe1-ebfc-44b8-aeb8-a0a1f2336224 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Philips Respironics DreamStation Style Disposable Filters |
| Version Model Number | ASUS002CF1010 |
| Company DUNS | 141668116 |
| Company Name | SUNSET HEALTHCARE SOLUTIONS, INC. |
| Device Count | 6 |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 877-578-6738 |
| customerservice@sunsethcs.com | |
| Phone | 877-578-6738 |
| customerservice@sunsethcs.com | |
| Phone | 877-578-6738 |
| customerservice@sunsethcs.com | |
| Phone | 877-578-6738 |
| customerservice@sunsethcs.com | |
| Phone | 877-578-6738 |
| customerservice@sunsethcs.com | |
| Phone | 877-578-6738 |
| customerservice@sunsethcs.com | |
| Phone | 877-578-6738 |
| customerservice@sunsethcs.com | |
| Phone | 877-578-6738 |
| customerservice@sunsethcs.com | |
| Phone | 877-578-6738 |
| customerservice@sunsethcs.com | |
| Phone | 877-578-6738 |
| customerservice@sunsethcs.com | |
| Phone | 877-578-6738 |
| customerservice@sunsethcs.com | |
| Phone | 877-578-6738 |
| customerservice@sunsethcs.com | |
| Phone | 877-578-6738 |
| customerservice@sunsethcs.com | |
| Phone | 877-578-6738 |
| customerservice@sunsethcs.com | |
| Phone | 877-578-6738 |
| customerservice@sunsethcs.com | |
| Phone | 877-578-6738 |
| customerservice@sunsethcs.com | |
| Phone | 877-578-6738 |
| customerservice@sunsethcs.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00848530103699 [Primary] |
| GS1 | 10848530103696 [Unit of Use] |
| 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 | 2024-03-19 |
| Device Publish Date | 2024-03-11 |
| 10848530102705 | Philips Respironics DreamStation Style Disposable Filters - 6/pack |
| 10848530103696 | Ultra Fine Filter Respironics DreamStation Disposable Filter (6/pack) |