Contract manufacturerICU Medical, Inc. (Dublin, OH)OhioAnesthesiologyGeneral hospitalCardiovascularGastroenterology and urologyPhysical medicineClass IIClass I
ICU Medical, Inc.
Contract manufacturer · Dublin, OH
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1526863 (openFDA record; or search FDA's registration database)
- FEI number
- 1526863
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer; Contract manufacturer; Repackager or relabeler
- Owner or operator
- ICU Medical, Inc. (FDA owner/operator no. 8020727)
- Registered address
- 6250 Shier Rings Rd, Dublin, OH 43016
- Contract listings
- 23 device listings, 14 product codes, first listed Sep 15, 2003
- 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 |
|---|---|---|---|---|---|
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | Class II | Anesthesiology | Contract manufacturing | Dec 20, 2007 |
| BWF | Spirometer, Therapeutic (Incentive) | Class II | Anesthesiology | Contract manufacturing | Aug 13, 2007 |
| BXR | Meter, Airway Pressure (Inspiratory Force) | Class II | Anesthesiology | Contract manufacturing | Aug 13, 2007 |
| BYF | Mask, Oxygen, Low Concentration, Venturi | Class I | Anesthesiology | Contract manufacturing | Sep 15, 2003 |
| BYI | Percussor, Powered-Electric | Class II | Anesthesiology | Contract manufacturing | Aug 13, 2007 |
| CAF | Nebulizer (Direct Patient Interface) | Class II | Anesthesiology | Contract manufacturing | Aug 13, 2007 |
| CAH | Filter, Bacterial, Breathing-Circuit | Class II | Anesthesiology | Contract manufacturing | Aug 13, 2007 |
| CAN | Regulator, Pressure, Gas Cylinder | Class I | Anesthesiology | Contract manufacturing | Aug 13, 2007 |
| CBD | Bottle, Collection, Breathing System (Calibrated) | Class II | General hospital | Contract manufacturing | Jan 4, 2007 |
| CBP | Valve, Non-Rebreathing | Class II | Anesthesiology | Contract manufacturing | Aug 13, 2007 |
| DXT | Injector And Syringe, Angiographic | Class II | Cardiovascular | Contract manufacturing | Jul 27, 2010 |
| FCE | Enema Kit | Class I | Gastroenterology and urology | Contract manufacturing | Jul 27, 2010 |
| FEN | Device, Cystometric, Hydraulic | Class II | Gastroenterology and urology | Contract manufacturing | Jul 27, 2010 |
| ION | Exerciser, Non-Measuring | Class I | Physical medicine | Contract manufacturing | Aug 13, 2007 |