# SunMed Group Holdings, LLC (specification developer, Grand Rapids, MI): 9 new FDA device listings, incl. blood pressure cuff

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | SunMed Group Holdings, LLC |
| Owner / operator | SunMed Group Holdings, LLC dba AirLife |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility |
| Location | Grand Rapids, MI, US |
| New listings | 9 |
| Devices | Blood Pressure Cuff; Tube, Tracheal (W/Wo Connector); Humidifier, Respiratory Gas, (Direct Patient Interface); Mask, Oxygen; Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase |
| Product codes | DXQ, BTR, BTT, BYG, CCK |
| Device classes | Class I, Class II |
| Medical specialties | Cardiovascular, Anesthesiology |
| Brand names | Disposable blood pressure cuff; tube, tracheal (w/wo connector) - EasyCurve Endotracheal tube, articulating cord, cuffed (PFEC); Endotrachael Tube, High; Salter Labs Bubble Humidifier; Flex Tip (PFTVPUS); Trach-Vac Endotracheal Tube with Flex Tip/PVC cuff & Stylet (PFTVVCS);; tube, tracheal (w/wo connector) - Salter Labs Trach-Vac Endotracheal Tube; Trach-Vac Endotracheal Tube with; Trach-Vac Endotracheal Tube with Flex Tip/PVC cuff (PFTVVC); Salter Humidifier; CapnoVue Masks |
| First new listing | 2026-05-06 |
| Latest new listing | 2026-08-26 |
| FDA registration number | 1314417 |
| Registration expires | 2027-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- 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.