# Covidien (specification developer, Lafayette, CO): 5 new FDA device listings, incl. burst suppression detection software for electroencephalograph

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | Covidien |
| Owner / operator | Covidien llc |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Develop Specifications But Do Not Manufacture At This Facility |
| Location | Lafayette, CO, US |
| New listings | 5 |
| Devices | Burst Suppression Detection Software For Electroencephalograph; Index-Generating Electroencephalograph Software; Reduced- Montage Standard Electroencephalograph; Non-Normalizing Quantitative Electroencephalograph Software; Tube, Tracheal (W/Wo Connector) |
| Product codes | ORT, OLW, OMC, OLT, BTR |
| Device classes | Class II |
| Medical specialties | Neurology, Anesthesiology |
| Brand names | BIS™ Advance pEEG Module; 18875 7.5MM TAPERGUARD EVAC TRACHEAL; 18865 6.5MM TAPERGUARD EVAC TRACHEAL 202; 18885 8.5MM TAPERGUARD EVAC TRACHEAL; 18890 9MM TAPERGUARD EVAC TRACHEAL; 18860 6MM TAPERGUARD EVAC TRACHAEL; 18870 7MM TAPERGUARD EVAC TRACHEAL; 18880 8MM TAPERGUARD EVAC TRACHEAL |
| First new listing | 2026-08-17 |
| Latest new listing | 2026-09-18 |
| FDA registration number | 2936999 |
| 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: 2026-11-04T21:52:36.524Z.
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.