Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9617594

FEI Number

3003807466

Entity Name

ICU MEDICAL DE MEXICO, S. de R.L. de C.V.

City/State/Country

ENSENADA, Baja California, MX

Establishment Address

Avenida Cuarzo No. 250, Colonia Rancho Santa Clara, Maneadero, ENSENADA, Baja California 22790, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Repack or Relabel Medical Device,Manufacture Medical Device

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

K080077

PMA Number

N/A

All Registered Proprietary Names

CLAVE Connector Smartvalve IV Ext Set Clave Ext Set Ext Set CLAVE Extension Sets Clave Neutral-Displacement Needlefree Connectors Expressions MR Transpac IV SetSource Ext Sets Primary IV Set Diana ChemoLock Transfer Set Vial Access Spike Rio Drug Reconstitution Transfer Device Safe Connector Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432 Cath Lab Kits Disposable Transducer Monitoring Kits Lopez Valve PICCOx Peripherally Inserted, Pressure Injectable, Central Venous Oximetry Catheter Safeset Dye Management System Pull Tab Squeeze Flush High Pressure Sets Antimicrobial CLAVE SwabTip Male Disinfectant Cap ADAPTOR, CATHETER Spinning Spiros Stopcock Extension Sets Piggy Lock CLAVE Vial Access Spike Cardiac Catheterization Kit PLUM 360 Infusion System CLAVE Connector Additive Hinge Cap Transpac IT Universal Vial Access Spike Thermoset Genie ChemoCLAVE Prep System SwabCap Bloof Tubing with Anti Regurgitation CLAVE Stopcock

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	1999-08-04
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	1999-08-04
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2010-02-18
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-06-12
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2010-02-07
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2006-11-20
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2019-02-21
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2006-11-20
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2020-11-19
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	1999-08-04
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
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2018-03-14
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2010-02-18
DQE	Catheter, Oximeter, Fiber-Optic	Cardiovascular	Class 2	870.1230	2014-08-12
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2010-02-18
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2010-02-18
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2008-10-24
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2008-09-22
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2011-01-11
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2010-02-18
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2010-02-18
QBP	Cap, Device Disinfectant	General Hospital	Class 2	880.5440	2021-04-22
GCE	Adaptor, Catheter	General, Plastic Surgery	Class 1	878.4200	2013-08-09
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2010-02-18
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2010-02-18
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	1999-08-04
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2010-02-18
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2010-02-18
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	1999-08-04
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2017-03-23
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2010-02-15
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2008-09-22
KRB	Probe, Thermodilution	Cardiovascular	Class 2	870.1915	2011-05-04
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2008-09-22
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
QBP	Cap, Device Disinfectant	General Hospital	Class 2	880.5440	2016-03-01
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Gastroenterology, Urology	Class 2	876.5820	2010-02-18
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2008-09-22
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2008-09-22

Official Correspondent

Michelle Doherty

US Agent Details

Michelle Doherty Business: ICU MEDICAL, INC. Email: michelle.doherty@icumed.com Phone: (949) 3706562

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
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
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
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-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
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

Similar Registrations

Registration Number	Establishment Name	Location
3018229072	INNOVATIVE HEALTH SCIENCES	Chester, NY, US
3030989877	INTERNATIONAL FILTER PRODUCTS DBA IFP MEDICAL	Sun Valley, CA, US
1047843	ISOMEDIX OPERATIONS INC.	SPARTANBURG, SC, US
3002807090	Sterigenics Germany GmbH	Wiesbaden Hesse, DE
3013319212	ICU MEDICAL, INC.	Lake Forest, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9617594. Last updated year: 2026. Please use registration number 9617594 when referencing this establishment in official correspondence.