# Home Health Us Incorporated (other, Sarasota, FL): 12 new FDA device listings, incl. pad, alcohol, device disinfectant

**Score:** 75/100

| Field | Value |
|---|---|
| Establishment | Home Health Us Incorporated |
| Owner / operator | Home Health US Inc |
| Role | Other |
| Establishment types | Complaint File Establishment per 21 CFR 820.198 |
| Location | Sarasota, FL, US |
| New listings | 12 |
| Devices | Pad, Alcohol, Device Disinfectant; Needle, Hypodermic, Single Lumen; Test, Cannabinoid, Over The Counter; Test, Methadone, Over The Counter; Test, Barbiturate, Over The Counter; Test, Phencyclidine (Pcp), Over The Counter; Test, Cocaine And Cocaine Metabolites, Over The Counter; Test, Amphetamine, Over The Counter; Test, Benzodiazepine, Over The Counter; Test, Opiates, Over The Counter |
| Product codes | LKB, FMI, NFW, PTG, PTH, NGM, NFY, NFT, NFV, NGL, NGG, QAW |
| Device classes | Class II, Unclassified |
| Medical specialties | General Hospital, Clinical Toxicology |
| Brand names | One Step; One Step® |
| First new listing | 2026-05-16 |
| Latest new listing | 2026-10-22 |
| FDA registration number | 3021186226 |
| Registration expires | 2027-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
- Listed in the last 45 days.

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: 2026-11-04T21:52:36.524Z.
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.