Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616567

FEI Number

3002963732

Entity Name

ICU Medical Healthcare Manufacturing S.A. de C.V.

City/State/Country

APODACA Nuevo Leon, MX

Establishment Address

CARRETERA MIGUEL ALEMAN, KM21.7, PARQUE INDUSTRIAL MONTERREY, APODACA Nuevo Leon 66603, MX

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ICU Medical, Inc. (Owner Number: 8020727)

Owner / Operator Contact Address

951 Calle Amanecer, San Clemente, CA 92673, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K911383

PMA Number

N/A

All Registered Proprietary Names

Trifurcated IV set Portex Pleural Catheters (IFE) Portex Thoracic Catheters (IFE) Portex Corrugated X-Ray Stripe Drains (IFE) Portex Tubes (IFE) Portex Yeates Drains (IFE) Portex Ambulatory Chest Kits (IFE) Medex Trigger Flush Device Bougie Portex Introducer Portex Respiratory Stylets (IFE) Portex Portex Endotracheal Tube (IFE) NORMOFLO SmartSite T- Connector Level 1® H-1200 Fast Flow Fluid Warmer various clamps and brackets TranStar (R) Pneupac paraPAC plus Disposable CPAP Circuit Pneupac paraPAC plus Portex Hydroflow Probes Portex Cholangiogram Buchanan Cannulas (IFE) Portex Single Use Airways (IFE) Portex Laryngeal Mask Portex Airway Guedel Oropharyngeal (IFE) Guedel Berman AIREASY OROPHARYNGEAL DHD LONG TERM ENDOT BIVONA SECUREEASY injection adapter HemoDraw® Plus Closed Blood Sampling System with LogiCal® Transducer System TranStar® Pressure Monitoring System IV admin set with minicheck valve Blue Line Manometer Connecting Tube (IFE) First Breath OXYGEN TUBING BIVONA Ultraset Mount Adapter Duralife Portex Oxygen/Aerosol Adapters and Connectors (IFE) Portex Oxygen/Aerosol Tubing (IFE) Industrial - Connectors (IFE) Connector RESCAL Portex Fibre-Optic Bronchoscope Swivel Connector (IFE) Swivel Elbow CIRCUVENT UNIVERSAL MOUTHPIECE Portex Airway Nasopharyngeal (IFE) Portex Portex Reinforced Endotracheal Tube TranStar Jelco® Venipuncture Needle-Pro® Device Low pressure ext. tubing High pressure ext. tubing Portex AquinOx First Breath Portex Nasal Oxygen set (IFE) OXYGEN NASAL CANNULA Level 1 Normothermic I.V. Fluid Administration Set Disposable Normothermic IV Administration Sets PVC - Portex Speaking Orator Medex Various IV administration sets Medex Central Venous Pressure Manometer Snuggle Warm® Blankets "SNUGGLE WARM" CONVE Portex BLUselect Tracheostomy Tube Portex BLUselect Suctionaid Tracheostomy Tube Portex BLUselect Tracheostomy Inner Cannula Contrast Control Device Contrast Manager Medex Bacterial Filter Equator® Convective Warmer Snuggle Warm® Convective Warming Blanket Aerogard Aeromist Level 1 (R) Fast Flow Fluid Warmer Needle-Pro Miniloop MEDEX STOPCOCK & LUER LOCK PLUG IV Filter sets Hemostatic Y various adapters and connectors HemoDraw Plus Closed Blood Sampling Set with LogiCal Transducer System HemoDraw Plus Closed Blood Sampling Set with TranStar Transducer System Thermovent Nu-site SmartSite LogiCal (R) Novadome Novatrans Transstar Mini-vol extension set LogiCal(R) Transfer Set HemoDraw humidification chambers Hotline Hotline 3

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	2007-11-28
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2009-11-26
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2007-11-28
FPK	Tubing, Fluid Delivery	General Hospital	Class 2	880.5440	2010-07-27
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2004-07-19
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2008-01-05
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2008-07-08
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-11-28
BSB	Warmer, Blood, Non-Electromagnetic Radiation	Hematology	Class 2	864.9205	2007-12-28
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2008-06-02
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2007-11-28
FEN	Device, Cystometric, Hydraulic	Gastroenterology, Urology	Class 2	876.1620	2010-07-27
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2013-09-24
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2013-09-24
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2018-12-21
GBZ	Catheter, Cholangiography	General, Plastic Surgery	Class 1	878.4200	2018-12-21
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2003-09-15
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2003-09-15
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-11-28
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2017-11-16
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-11-28
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2003-09-15
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	1992-10-02
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2003-09-15
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	1993-01-13
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2007-12-04
DPT	Probe, Blood-Flow, Extravascular	Cardiovascular	Class 2	870.2120	2008-03-03
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2007-12-19
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2010-07-27
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2003-09-15
KZL	Device, Warming. Blood And Plasma	Hematology	Class 2	864.9205	2007-12-28
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2018-09-10
FPB	Filter, Infusion Line	General Hospital	Class 2	880.5440	2007-11-28
KRK	Manometer, Blood-Pressure, Venous	Cardiovascular	Class 2	870.1140	2007-11-28
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	1994-06-29
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2018-11-09
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-11-28
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2007-11-28
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2015-02-16
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2007-11-28
BSB	Warmer, Blood, Non-Electromagnetic Radiation	Hematology	Class 2	864.9205	2007-12-28
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2007-12-19
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-11-28
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2020-02-27
FPB	Filter, Infusion Line	General Hospital	Class 2	880.5440	2007-11-28
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2007-11-28
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2017-08-16
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2018-09-07
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-11-28
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2007-11-28
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-11-28
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2007-11-28
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2010-07-27
CBT	Arterial Blood Sampling Kit	Anesthesiology	Class 1	868.1100	2007-11-28
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2007-11-28
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2007-12-28

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
3008818980	ICU Medical, Inc.	Olive Branch, MS, US
3004187702	ICU Medical (SM Prodotti) Italia S.r.L.	Latina Scalo - LT, IT
3011237704	ICU Medical Czech Republic a. s.	Hranice Olomoucky Kraj, CZ
1824231	ICU Medical, Inc.	Gary, IN, US
1526863	ICU Medical, Inc.	DUBLIN, OH, US

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 9616567. Last updated year: 2026. Please use registration number 9616567 when referencing this establishment in official correspondence.