Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2025816

FEI Number

2025816

Entity Name

ICU MEDICAL, INC.

City/State/Country

SAN CLEMENTE, CA, US

Establishment Address

951 CALLE AMANECER, SAN CLEMENTE, CA 92673, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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

K954813

PMA Number

N/A

All Registered Proprietary Names

Additive Hinge Cap Rio Drug Reconstitution Transfer Device Vial Access Spike Universal Vial Access Spike ClearGuard HD Antimicrobial barrier cap SetSource Ext Sets Primary IV Set Universal Spikes Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432 NovaCath IV Ext Set Clave Ext Set Ext Set CLAVE Extension Sets Safe Connector Clave Neutral-Displacement Needlefree Connectors ChemoCLAVE Prep System Rio Drug Reconstitution Transfer Device ChemoCLAVE Prep System NovaCath ADAPTOR, CATHETER Cogent Hemodynamic Monitoring System Catheter, oximeter, fiber-optic TEGO Bloof Tubing with Anti Regurgitation Diana Compounding Workflow System Diana Cath Lab Kits SwabTip Male Disinfectant Cap Blood Banking Extension Sets

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2017-03-23
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2025-06-12
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2006-11-20
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2008-09-22
PEH	Hemodialysis Catheter Luer End Cap	Gastroenterology, Urology	Class 2	876.5540	2020-10-07
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2006-11-20
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2010-02-18
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2010-02-18
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2016-09-20
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2010-02-18
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	1999-08-04
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-06-12
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-09-22
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2008-09-22
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2020-11-19
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2018-10-10
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2018-10-10
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2018-10-10
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2016-09-20
GCE	Adaptor, Catheter	General, Plastic Surgery	Class 1	878.4200	2013-08-09
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2017-05-12
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2017-05-12
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
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-09-22
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Gastroenterology, Urology	Class 2	876.5820	2010-02-18
NEP	System/Device, Pharmacy Compounding	General Hospital	Class 2	880.5440	2011-11-08
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2008-10-24
QBP	Cap, Device Disinfectant	General Hospital	Class 2	880.5440	2021-04-22
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	1999-08-04

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
2024064	ICU MEDICAL, INC.	SAN DIEGO, CA, US
1713468	ICU MEDICAL, INC	Salt Lake City, UT, US
3013319212	ICU MEDICAL, INC.	Lake Forest, IL, US
9615050	ICU Medical Costa Rica Ltd.	La Aurora de Heredia, CR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K041415	B.Braun Medical, Inc.	EVA TPN CONTAINER	2004-08-04
K243985	Icu Medical, Inc.	Rio Drug Reconstitution Transfer Device	2025-01-22
K222718	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	Vial Adapter	2023-03-10
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Z-0002-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 3000mL, (legless) REF 66630 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Z-0003-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) REF 66640 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Z-0004-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 1500mL, REF 66616 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Z-0005-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 3000mL, REF 66631 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2025816. Last updated year: 2026. Please use registration number 2025816 when referencing this establishment in official correspondence.