| Primary Device ID | 00848530108441 |
| NIH Device Record Key | 7eadf446-6897-4c93-9a4a-932a1e6eaf9d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Repair Part |
| Version Model Number | RP068 |
| 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 | false |
| 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 | 00848530108441 [Primary] |
| BYX | Tubing, Pressure And Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-02 |
| Device Publish Date | 2026-02-20 |
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| 10848530108257 | Spacers for Drive Rotary Rebuilt Valves - 10/PK |
| 10848530108240 | Drive Rotary Rebuilt Valve Kit |
| 10848530108226 | Drive Capacitor SSP 5 Liter (OEM# 525D-616) |
| 00848530108458 | Companion C21/C41 Secondary Relief Valve, 30 PSI (OEM# B-775139-00) |
| 00848530108441 | C1000/C1000T Primary Relief Valve, 22 PSI (OEM# B-776892-00) |