| Primary Device ID | 10848530108240 |
| NIH Device Record Key | be6b3e7f-690c-4e0e-b4e8-80d7edfc0f46 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | REPAIR PART |
| Version Model Number | RP094 |
| 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 | 00848530108243 [Primary] |
| GS1 | 10848530108240 [Package] Contains: 00848530108243 Package: [48 Units] In Commercial Distribution |
| OGL | Oxygen Administration Kit |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-27 |
| Device Publish Date | 2026-01-19 |
| 10848530104266 | PE Valve for Invacare Platinum (IRC10LXO2, IRC5LXO2), Perfecto (IRC5PO2) and the PerfectoV (IRC5 |
| 00848530107659 | Lip Seal for Helios - Metal |
| 10848530108257 | Spacers for Drive Rotary Rebuilt Valves - 10/PK |
| 10848530108240 | Drive Rotary Rebuilt Valve Kit |
| 10848530108226 | Drive Capacitor SSP 5 Liter (OEM# 525D-616) |