# Cook Medical LLC (contract manufacturer, Bloomington, IN): 4 new FDA device listings, incl. tube, tracheal (w/wo connector)

**Score:** 90/100

| Field | Value |
|---|---|
| Establishment | Cook Medical LLC |
| Owner / operator | Cook Medical |
| Role | Contract manufacturer |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Bloomington, IN, US |
| New listings | 4 |
| Devices | Tube, Tracheal (W/Wo Connector); Wire, Guide, Catheter; Catheter, Urological; Catheter, Ureteral, Gastro-Urology |
| Product codes | BTR, DQX, KOD, EYB |
| Device classes | Class II |
| Medical specialties | Anesthesiology, Cardiovascular, Gastroenterology, Urology |
| Brand names | Frova Intubating Introducer; DC Wire Guides; Lunderquist® Extra Stiff Wire Guide; Open-End Flexi-Tip Ureteral Catheter; Pediatric Ureteral Catheter; Flexi-Tip Ureteral Catheter (Right); Whistle Tip Ureteral Catheter (Left); Open-End Beveled Flexi-Tip Ureteral Catheter |
| First new listing | 2026-07-15 |
| Latest new listing | 2026-10-13 |
| FDA registration number | 3005580113 |
| Registration expires | 2027-12-31 |

## Why this score
- Contract manufacturer or sterilizer adding work.
- 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.