Data / Medical devices / Mexico / ICU MEDICAL DE MEXICO, S. de R.L. de C.V.
ICU MEDICAL DE MEXICO, S. de R.L. de C.V.: FDA-registered device maker in ENSENADA, Baja California, Mexico, 51 510(k) clearances
ICU MEDICAL DE MEXICO, S. de R.L. de C.V. is registered with the FDA (registration 9617594) in ENSENADA, Baja California, Mexico. It lists 24 device types. The FDA files 51 510(k) clearances under its listings, the newest dated April 20, 2020. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 9617594
- FEI number
- 3003807466
- Address
- Avenida Cuarzo No. 250 Colonia Rancho Santa Clara, Maneadero, ENSENADA, Baja California, Mexico, 22790
- Owner or operator
- ICU MEDICAL, INC. (2025816)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- August 4, 1999
- Registered through
- 2026
- Brand names listed
- ADAPTOR, CATHETER, Additive Hinge Cap, Antimicrobial CLAVE, Blood Banking Extension Sets, Bloof Tubing with Anti Regurgitation, CLAVE Connector, CLAVE Extension Sets, CLAVE Stopcock and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Catheter | KGZ | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Accessories, Catheter, G-U | KNY | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Adaptor, Catheter | GCE | 1 | Manufacturer | accessdata.fda.gov |
| Cap, Device Disinfectant | QBP | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Catheter, Continuous Flush | KRA | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Catheter, Intravascular, Diagnostic | DQO | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Oximeter, Fiber-Optic | DQE | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Catheter, Straight | EZD | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | ONB | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Container, I.V. | KPE | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Infusion Safety Management Software | PHC | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Probe, Thermodilution | KRB | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Pump, Infusion | FRN | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Set, I.V. Fluid Transfer | LHI | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | FJK | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Stopcock, I.V. Set | FMG | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Transducer, Blood-Pressure, Extravascular | DRS | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tubes, Gastrointestinal (And Accessories) | KNT | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tubing, Fluid Delivery | FPK | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 20, 2020 | K192154 | Rio Vial-to-Bag Drug Reconstitution Device | LHI | Substantially Equivalent | Icu Medical | accessdata.fda.gov |
| March 6, 2020 | K190918 | SwabTip Male Disinfectant Cap | QBP | Substantially Equivalent | Icu Medical | accessdata.fda.gov |
| August 31, 2018 | K173477 | ChemoCLAVE Cytotoxic Medication Preparation and Delivery System | ONB | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| August 10, 2018 | K170110 | Diana Medication Transfer Set | ONB | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| March 11, 2016 | K160374 | 20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System | FOZ | Substantially Equivalent | Tangent Medical Technologies, Inc. | accessdata.fda.gov |
| January 16, 2015 | K141789 | PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE | FRN | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| July 2, 2014 | K140129 | PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER | DQE | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| December 24, 2013 | K130975 | SWABCAP AND SWABFLUSH | QBP | Substantially Equivalent | Excelsior Medical Corp. | accessdata.fda.gov |
| July 26, 2013 | K131549 | CHEMOLOCK, CHEMOLOCK PORT | ONB | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| July 20, 2012 | K120839 | NOVACATH SECURE IV CATHETER SYSTEM-18G | FOZ | Substantially Equivalent | Tangent Medical Technologies, Inc. | accessdata.fda.gov |
| December 17, 2010 | K100576 | HIGH PRESSURE SETS-400 PSI | FPA | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| July 9, 2010 | K100434 | CLAVE NEUTRON | FPA | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| April 10, 2009 | K090189 | ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE | FPA | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| April 6, 2009 | K082806 | SPINNING SPIROS, MODEL CH-2000 | FPA | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| February 25, 2009 | K082836 | ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES | FMG | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| August 28, 2008 | K081361 | CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX | FPA | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| May 13, 2008 | K080007 | GRADUATED ADAPTER WITH CLAVE | EZD | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| May 2, 2008 | K080989 | UNIVERSAL VIAL ACCESS SPIKE | FMF | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| February 13, 2008 | K080077 | CLAVE STOPCOCK | FMG | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| September 19, 2007 | K070979 | PULL TAB SQUEEZE FLUSH | KRA | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| June 5, 2007 | K070633 | GENIE, MODEL CH-200 | FMF | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| March 20, 2007 | K070532 | SPIROS | FPA | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| September 19, 2006 | K061573 | TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT | DRS | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| February 17, 2006 | K052828 | DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT) | DRS | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| January 10, 2006 | K053106 | TEGO, MODEL D1000 | FPA | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| December 22, 2005 | K052865 | HOSPIRA CATH LAB CONVENIENCE KITS | DQO | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| September 1, 2004 | K042182 | Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432 | FPA | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| December 24, 1998 | K983559 | BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR | FJK | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| January 9, 1998 | K974589 | SMARTVALVE | FPA | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| June 24, 1997 | K970855 | CLAVE CONNECTOR | FPA | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| April 2, 1997 | K964435 | PRIMARY IV SET | FMG | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| November 29, 1995 | K954813 | ICU EXTENSION KIT | FPA | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| October 7, 1995 | K953573 | ICU STOPCOK WITH EXTENSION TUBING | FMG | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| January 31, 1995 | K941190 | CLAVE NEEDLE-LESS CONNECTOR OPEN EXTENSION SET | FPA | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| December 13, 1994 | K941978 | HIGH PRESSURE TUBING | DQO | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| October 3, 1994 | K941214 | LIFESHIELD EXTENSION SET | FPK | Substantially Equivalent | Abbott Mfg., Inc. | accessdata.fda.gov |
| September 22, 1994 | K932141 | CARDIAC CATHETERIZATION KIT | DQO | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| June 13, 1994 | K941254 | DYE MANAGEMENT SYSTEM | DQO | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| February 22, 1994 | K940296 | SAFE CONNECTOR | FPA | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| February 16, 1994 | K934591 | CLAVE VIAL ACCESS SPIKE | FMI | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| February 10, 1994 | K934561 | ONE TIME VIAL ACCESS SPIKE | FMF | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| October 25, 1993 | K932188 | SAFESET RESERVOIR | KRA | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| June 18, 1993 | K923966 | SYRINGE ADAPTOR | LHI | Substantially Equivalent | Excel Medical, Inc. | accessdata.fda.gov |
| September 21, 1992 | K915571 | CLAVE CONNECTOR | FPA | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| June 3, 1992 | K914299 | CARDIAC CATHERIZATION KIT | DQO | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| February 11, 1992 | K913804 | EXCELSIOR SINGLE LEAD DISPENSING SET | LHI | Substantially Equivalent | Excel Medical, Inc. | accessdata.fda.gov |
| February 7, 1992 | K915171 | LOPEZ VALVE TM II | KNT | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| April 29, 1991 | K910546 | PIGGY LOCK NEEDLE HOUSING | FPA | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| December 13, 1988 | K884318 | THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM | KRB | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| August 12, 1983 | K831506 | DISP. TRANSDUCER W/MONITORING KIT TRANS | DRS | Substantially Equivalent | Sorensen Research | accessdata.fda.gov |
| October 1, 1979 | K791796 | ADDITIVE HINGE CAP | KPE | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 1, 2018 | 80460 | Class II | Terminated | 20 cm (8") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a p | ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold. | accessdata.fda.gov |
Compare with other makers
- All makers of Set, Administration, Intravascular
- All makers of Set, I.V. Fluid Transfer
- All makers of Catheter, Intravascular, Diagnostic
- All makers of Accessories, Catheter
- All makers of Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
- All makers of Catheter, Straight
Updated April 20, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.