| Primary Device ID | 10848530107281 |
| NIH Device Record Key | e28703a6-77cd-4d1b-b037-88b15084200f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Heat Moisture Exchanger |
| Version Model Number | RES027ILLV |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| 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 | |
| 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 | 00848530107284 [Primary] |
| GS1 | 10848530107281 [Package] Contains: 00848530107284 Package: [50 Units] In Commercial Distribution |
| BYD | Condenser, Heat And Moisture (Artificial Nose) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-27 |
| Device Publish Date | 2025-08-19 |
| 00848530083298 | Disposable, In-line HME |
| 00848530083274 | Heat Moisture Exchange Large Volume |
| 10848530103634 | Sunset Trach HME with O2 Port (OEM# 1190) |
| 20848530096957 | Sunset T HME with O2 Port |
| 20848530096940 | Sunset Healthcare Mini in-line HME, for neonatal |
| 20848530096926 | Sunset Flex HME |
| 00848530096908 | Sunset T HME |
| 20848530062310 | T Heat Moisture Exchanger |
| 10848530107281 | Sunset Adult In-line Large Volume HME with Gas Sampling Port |