MedtechSourcebook

ICU MEDICAL, INC

Contract manufacturer · Salt Lake City, UT

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

FDA registration
1713468 (openFDA record; or search FDA's registration database)
FEI number
1713468
Registered for
FDA registration year 2026
Establishment types
Specification developer; Manufacturer; Contract manufacturer; Repackager or relabeler
Owner or operator
ICU MEDICAL, INC. (FDA owner/operator no. 2025816)
Registered address
4455 ATHERTON DR., Salt Lake City, UT 84123
Contract listings
9 device listings, 7 product codes, first listed Nov 20, 2006
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 codeDevice (FDA name)ClassCategoryRoleFirst listed
DRSTransducer, Blood-Pressure, ExtravascularClass IICardiovascularContract manufacturingFeb 7, 2010
FMGStopcock, I.V. SetClass IIGeneral hospitalContract manufacturingNov 20, 2006
FPASet, Administration, IntravascularClass IIGeneral hospitalContract manufacturingSep 22, 2008
KRACatheter, Continuous FlushClass IICardiovascularContract manufacturingSep 22, 2008
KRBProbe, ThermodilutionClass IICardiovascularContract manufacturingMay 4, 2011
LHISet, I.V. Fluid TransferClass IIGeneral hospitalContract manufacturingSep 22, 2008
QBPCap, Device DisinfectantClass IIGeneral hospitalContract manufacturingMar 1, 2016