| Primary Device ID | 10848530108219 |
| NIH Device Record Key | 948720e9-703b-4040-bf15-ecf36e74d3ec |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Oxygen, Bacteria & HEPA Filter |
| Version Model Number | OF7005-10 |
| 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 | 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 | 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 | 00848530108212 [Primary] |
| GS1 | 10848530108219 [Package] Contains: 00848530108212 Package: [100 Units] In Commercial Distribution |
| GS1 | 20848530108216 [Package] Package: [10 Units] In Commercial Distribution |
| 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 | 2026-03-17 |
| Device Publish Date | 2026-03-09 |
| 00084853000905 | Filter, Hydrophobic, Set, Barb 3/pack |
| 10848530108219 | Inogen G4/G5 Output Filter (OEM: RP-410) - 10/PK |
| 10848530108202 | Inogen G2/G3 Output Filter (OEM: RP-101) - 10/PK |