Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013319212

FEI Number

3013319212

Entity Name

ICU MEDICAL, INC.

City/State/Country

Lake Forest, IL, US

Establishment Address

600 N Field Dr, Lake Forest, IL 60045, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

ICU MEDICAL, INC. (Owner Number: 2025816)

Owner / Operator Contact Address

951 Calle Amanecer, --, San Clemente, CA 92673, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Effective Cap Extension Set Advanced Sensor Catheter Decanting Set Plum Solo Precision IV Pump PLUM 360 Infusion System Sapphire Sets Primary Set Transpac IT Diana ChemoLock Transfer Set CLAVE Connector Catheter, Flow Directed Lifecare 5000 Infusion System Primary Set Primary Set Extension Set Burette Set Sapphire Set Two-Way Transfer Device PLUM A+ Infusion System ClearGuard HD Antimicrobial barrier cap Additive Hinge Cap PLUM A+ Infusion System NovaCath ICU Medical MedNet Medication Management Suite Infusion Set Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432 Cath Lab Kits Infusion Set Omni Flow Infusion System Dye Management System CVP Polyurethane Catheter W Heparin (No Balloon) Plum Duo Precision IV Pump Infusion Blood Set Nutrimix Empty Container Flow Directed Thermal-Dilution Infusion Sterile Empty Container PLUM XL Infusion System PLUM A+ Infusion System Plum DuoTM Infusion System Extension Set Opticath Lifecare PCA Infusion system Irrigation Set PLUM XL Infusion System PLUM XL Infusion System Cogent Hemodynamic Monitoring System PLUM 360 Infusion System Infusion System SwabTip Male Disinfectant Cap LifeShield Infusion Safety Software Suite Blood Set Lifecare PCA Infusion System Sapphire Sets Vital Signs Wireless Monitoring System SwabCap Empty Container and Infusion Set Opticath, Heparin Coated PICCOx Peripherally Inserted, Pressure Injectable, Central Venous Oximetry Catheter Diana Compounding Workflow System Diana

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QBP	Cap, Device Disinfectant	General Hospital	Class 2	880.5440	2017-02-20
ODA	Endoscopic Central Control Unit	Gastroenterology, Urology	Class 2	876.1500	2017-02-17
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-02-17
DQE	Catheter, Oximeter, Fiber-Optic	Cardiovascular	Class 2	870.1230	2010-02-15
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2010-02-15
KRB	Probe, Thermodilution	Cardiovascular	Class 2	870.1915	2010-02-15
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2017-02-20
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2025-04-07
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2017-02-17
PHC	Infusion Safety Management Software	General Hospital	Class 2	880.5725	2017-02-17
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-02-17
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-02-17
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2017-02-17
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-02-17
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2010-02-15
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2019-02-21
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	1999-08-04
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2010-11-23
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2017-02-17
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-02-20
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-02-17
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-02-17
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-02-17
MRZ	Accessories, Pump, Infusion	General Hospital	Class 2	880.5725	2017-08-28
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2018-04-16
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2017-02-17
PEH	Hemodialysis Catheter Luer End Cap	Gastroenterology, Urology	Class 2	876.5540	2020-10-07
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2017-03-23
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2017-02-17
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2016-09-20
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2017-02-19
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-02-17
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2010-02-18
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2008-10-24
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-02-21
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2017-02-17
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2008-10-24
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2010-02-18
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2025-04-07
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-02-17
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2017-02-17
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2010-11-23
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2017-02-17
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2017-02-17
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2017-02-17
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2023-09-07
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-02-17
DQE	Catheter, Oximeter, Fiber-Optic	Cardiovascular	Class 2	870.1230	2010-09-22
MEA	Pump, Infusion, Pca	General Hospital	Class 2	880.5725	2017-02-17
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2017-02-21
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2017-02-17
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2017-02-19
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2017-05-12
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2017-05-12
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2017-04-11
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-04-11
PHC	Infusion Safety Management Software	General Hospital	Class 2	880.5725	2017-04-11
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-02-17
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2017-02-17
QBP	Cap, Device Disinfectant	General Hospital	Class 2	880.5440	2021-04-22
PHC	Infusion Safety Management Software	General Hospital	Class 2	880.5725	2023-08-28
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-02-17
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-02-17
MEA	Pump, Infusion, Pca	General Hospital	Class 2	880.5725	2017-02-17
MRZ	Accessories, Pump, Infusion	General Hospital	Class 2	880.5725	2017-02-20
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2010-02-15
QBP	Cap, Device Disinfectant	General Hospital	Class 2	880.5440	2016-03-01
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2017-02-17
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2010-11-23
DQE	Catheter, Oximeter, Fiber-Optic	Cardiovascular	Class 2	870.1230	2014-08-12
NEP	System/Device, Pharmacy Compounding	General Hospital	Class 2	880.5440	2011-11-08

Official Correspondent

Michelle Doherty

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ICU MEDICAL, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9617594	ICU MEDICAL DE MEXICO, S. de R.L. de C.V.	ENSENADA, Baja California, MX
2025816	ICU MEDICAL, INC.	SAN CLEMENTE, CA, US
2024064	ICU MEDICAL, INC.	SAN DIEGO, CA, US
1713468	ICU MEDICAL, INC	Salt Lake City, UT, US
9615050	ICU Medical Costa Rica Ltd.	La Aurora de Heredia, CR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18
K982672	Baxter Healthcare Corp	COLLEAGUE PUMP SYRINGE ADAPTER SET	1998-09-04
K143446	Roche Diagnostics GmbH	Accu-Chek FlexLink Plus infusion set	2015-08-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2012	Hospira Inc.	2	Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 11971 b) list 11973 - software version 10.3 c) list 12391 - software version 11.3 d) list 20679 - Hospira MedNet Software e) list 20792 - Driver Product Usage: The Plum A+ dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With their primary line, secondary line, and piggyback fluid delivery capability, the Plum A+ is suited for a wide range of medical/surgical and critical care applications. Full compatibility with LifeCare Plum Series administration sets and accessories and the LifeShield needleless protection systems makes the Plum A+ a convenient and cost-effective infusion system.
Z-0010-2012	Hospira Inc.	2	Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software version 11.3; c) list 20678 - Hospira MedNet software Product Usage: The Plum A+3 is a dual-line triple channel volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With their primary line, secondary line, and piggyback fluid delivery capability, the Plum A+3 is suited for a wide range of medical/surgical and critical care applications. Full compatibility with LifeCare Plum Series administration sets and accessories and the LifeShield needleless protection systems makes the Plum A+3 a convenient and cost-effective infusion system.
Z-0011-2012	Hospira Inc.	2	Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list 11005 Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace and multiplace chambers.
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24

Similar Registrations

Registration Number	Establishment Name	Location
3031757047	Solventum US LLC	Brookings, SD, US
1713468	ICU MEDICAL, INC	Salt Lake City, UT, US
1423662	Sterigenics US LLC	Gurnee, IL, US
3036497156	Solventum US LLC	Columbia, MO, US
3010882065	HEALTH LINE INTERNATIONAL CORPORATION	Salt Lake City, UT, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013319212. Last updated year: 2026. Please use registration number 3013319212 when referencing this establishment in official correspondence.