Contract manufacturerCOOK MEDICAL LLC (Bloomington, IN)IndianaCardiovascularGastroenterology and urologyGeneral and plastic surgeryGeneral hospitalClass IIClass IUnclassified
COOK MEDICAL LLC
Contract manufacturer ยท Bloomington, IN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3005580113 (openFDA record; or search FDA's registration database)
- FEI number
- 3005580113
- Registered for
- FDA registration year 2027
- Establishment types
- Complaint file establishment; Contract manufacturer
- Owner or operator
- COOK MEDICAL (FDA owner/operator no. 9090900)
- Registered address
- 400 DANIELS WAY, Bloomington, IN 47404
- Contract listings
- 12 device listings, 9 product codes, first listed Nov 14, 2013
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| DQX | Wire, Guide, Catheter | Class II | Cardiovascular | Contract manufacturing | Nov 14, 2013 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | Class II | Cardiovascular | Contract manufacturing | Nov 13, 2023 |
| DYB | Introducer, Catheter | Class II | Cardiovascular | Contract manufacturing | Jun 12, 2023 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | Class II | Gastroenterology and urology | Contract manufacturing | May 20, 2025 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Class II | Gastroenterology and urology | Contract manufacturing | Mar 7, 2022 |
| GBO | Catheter, Nephrostomy, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Nov 13, 2023 |
| JOL | Catheter And Tip, Suction | Class II | General hospital | Contract manufacturing | Feb 18, 2025 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Class II | Gastroenterology and urology | Contract manufacturing | Aug 11, 2025 |
| LJE | Catheter, Nephrostomy | Unclassified | Gastroenterology and urology | Contract manufacturing | Nov 13, 2023 |