# SUNSET HEALTHCARE SOLUTIONS, Inc. (repackager or relabeler, Chicago, IL): 3 new FDA device listings, incl. device, positive pressure breathing, intermittent

**Score:** 65/100

| Field | Value |
|---|---|
| Establishment | SUNSET HEALTHCARE SOLUTIONS, Inc. |
| Owner / operator | Sunset Healthcare Solutions |
| Role | Repackager or relabeler |
| Establishment types | Repack or Relabel Medical Device; Complaint File Establishment per 21 CFR 820.198 |
| Location | Chicago, IL, US |
| New listings | 3 |
| Devices | Device, Positive Pressure Breathing, Intermittent; Bandage, Liquid, Skin Protectant; Protector, Skin Pressure |
| Product codes | NHJ, NEC, FMP |
| Device classes | Class I, Class II |
| Medical specialties | Anesthesiology, General Hospital |
| Brand names | Cough Assist; Petroleum-free skin protectant/moisturizing emollient; Sunset Nasal Gel Pad |
| First new listing | 2026-05-07 |
| Latest new listing | 2026-09-01 |
| FDA registration number | 3006446479 |
| Registration expires | 2026-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.