ICU Medical, Inc.

Entity profile compiled from public source records

Public Record Profile Registrations: 17 510(k) filings: 1 Recalls: 0

Known Identifiers & Locations

FEI Numbers 1219611, 1526863, 1713468, 1824231, 2024064, 2025816, 3002558692, 3002963732, 3002999813, 3003807466, 3004187702, 3008818980, 3011237704, 3012307300, 3012542015, 3013319212, 3027579175
Owner Operator Numbers 2025816, 8020727
Locations Covered APODACA Nuevo Leon, MX; DUBLIN, OH, US; ENSENADA, Baja California, MX; Gary, IN, US; Highland, IN, US; Hranice Olomoucky Kraj, CZ; La Aurora de Heredia, CR; Lake Forest, IL, US; Latina Scalo - LT, IT; Minneapolis, MN, US; Olive Branch, MS, US; SAN CLEMENTE, CA, US; SAN DIEGO, CA, US; SOUTHINGTON, CT, US; Salt Lake City, UT, US; Tijuana, B.C. C.P. Baja California, MX; Wijchen Gelderland, NL

Registered Establishments (17)

Registration # Establishment Name Location Establishment Type(s) Action
1219611 ICU Medical, Inc. SOUTHINGTON, CT, US Manufacture Medical Device View Details
1526863 ICU Medical, Inc. DUBLIN, OH, US Manufacture Medical Device View Details
1713468 ICU MEDICAL, INC Salt Lake City, UT, US Develop Specifications But Do Not Manufacture At This Facility View Details
1824231 ICU Medical, Inc. Gary, IN, US Manufacture Medical Device View Details
2024064 ICU MEDICAL, INC. SAN DIEGO, CA, US Develop Specifications But Do Not Manufacture At This Facility View Details
2025816 ICU MEDICAL, INC. SAN CLEMENTE, CA, US Develop Specifications But Do Not Manufacture At This Facility View Details
3004187702 ICU Medical (SM Prodotti) Italia S.r.L. Latina Scalo - LT, IT Manufacture Medical Device View Details
3008818980 ICU Medical, Inc. Olive Branch, MS, US Manufacture Medical Device View Details
3011237704 ICU Medical Czech Republic a. s. Hranice Olomoucky Kraj, CZ Manufacture Medical Device View Details
3012307300 ICU Medical, Inc. Minneapolis, MN, US Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility View Details
3012542015 ICU Medical Nederland B.V. Wijchen Gelderland, NL Export Device to the United States But Perform No Other Operation on Device View Details
3013319212 ICU MEDICAL, INC. Lake Forest, IL, US Complaint File Establishment per 21 CFR 820.198 View Details
3027579175 ICU Medical, Inc. Highland, IN, US Manufacture Medical Device View Details
9615050 ICU Medical Costa Rica Ltd. La Aurora de Heredia, CR Manufacture Medical Device View Details
9616567 ICU Medical Healthcare Manufacturing S.A. de C.V. APODACA Nuevo Leon, MX Manufacture Medical Device View Details
9617594 ICU MEDICAL DE MEXICO, S. de R.L. de C.V. ENSENADA, Baja California, MX Manufacture Medical Device for Another Party (Contract Manufacturer),Repack or Relabel Medical Device,Manufacture Medical Device View Details
9617604 ICU Medical Healthcare Manufacturing S.A. de C.V. Tijuana, B.C. C.P. Baja California, MX Manufacture Medical Device View Details

510(k) Premarket Notifications (1)

Submission # Device Name Decision Date Decision Description Action
K243985 Rio™ Drug Reconstitution Transfer Device 2025-01-22 Substantially Equivalent View Details

FDA Recall History (0)

No recall records found for this entity.

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