| Primary Device ID | 10848530108127 |
| NIH Device Record Key | 5609feb3-7899-4a7f-9bd2-f715500ee1a0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Regulator |
| Version Model Number | RES048SD |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00848530108120 [Primary] |
| GS1 | 10848530108127 [Package] Contains: 00848530108120 Package: [20 Units] In Commercial Distribution |
| CAN | Regulator, Pressure, Gas Cylinder |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-03 |
| Device Publish Date | 2026-01-26 |
| 10848530108158 | Standard CGA 870 Regulator, 1 DISS, 0-25LPM - BULK |
| 10848530108127 | Standard CGA 870 Regulator, 1-DISS, 0-25LPM |