# Icu Medical, Inc. (specification developer, Lake Forest, IL): 45 new FDA device listings, incl. pump, infusion

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | Icu Medical, Inc. |
| 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 | Lake Forest, IL, US |
| New listings | 45 |
| Devices | Pump, Infusion; Warmer, Blood, Non-Electromagnetic Radiation; Set, Administration, Intravascular; System, Thermal Regulating; Warmer, Thermal, Infusion Fluid; Accessories, Pump, Infusion; Pump, Infusion, Pca; Device, Warming. Blood And Plasma; Medical Device Data System; Infusion Safety Management Software |
| Product codes | FRN, BSB, FPA, DWJ, LGZ, MRZ, MEA, KZL, OUG, PHC |
| Device classes | Class I, Class II |
| Medical specialties | General Hospital, Hematology, Cardiovascular |
| Brand names | Pump, infusion; Warmer, blood, non-electromagnetic radiation; Set, administration, intravascular; System, thermal regulating; Warmer, thermal, infusion fluid; Accessories, pump, infusion; Pump, infusion, pca; DEVICE, WARMING. BLOOD AND PLASMA |
| First new listing | 2026-07-13 |
| Latest new listing | 2026-07-21 |
| FDA registration number | 3013319212 |
| Registration expires | 2026-12-31 |

## 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.