BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

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

    Reg #: 9616567 · FEI: 3002963732 · Expires 2026
    View on FDA
    Products
    49
    Proprietary Names
    130
    Establishment Types
    3
    Classifications
    49

    Registration Details

    Registration Name
    ICU Medical Healthcare Manufacturing S.A. de C.V.
    Registration Number
    9616567
    FEI Number
    3002963732
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    CARRETERA MIGUEL ALEMAN, KM21.7, PARQUE INDUSTRIAL MONTERREY
    City
    APODACA Nuevo Leon
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K841882

    Owner / Operator

    Firm Name
    ICU Medical, Inc.
    Operator Number
    8020727
    Address
    951 Calle Amanecer
    City
    San Clemente
    State
    CA
    Postal Code
    92673
    Country
    US
    Correspondent
    Michelle Doherty

    US Agent

    Business Name
    ICU Medical, Inc.
    Contact Name
    Michelle Doherty
    Address
    951 Calle Amanecer
    City
    San Clemente
    State
    CA
    ZIP
    92673
    Country
    US
    Email
    [email protected]
    Phone
    949 3706562

    Products

    Device Name Product Code
    Set, Administration, Intravascular FPA
    Catheter, Irrigation GBX
    Catheter, Continuous Flush KRA
    Tubing, Fluid Delivery FPK
    Stylet, Tracheal Tube BSR
    Tube, Tracheal (W/Wo Connector) BTR
    Warmer, Thermal, Infusion Fluid LGZ
    Warmer, Blood, Non-Electromagnetic Radiation BSB
    Stand, Infusion FOX
    Device, Monitoring, Intracranial Pressure GWM
    Device, Cystometric, Hydraulic FEN
    Ventilator, Emergency, Powered (Resuscitator) BTL
    Attachment, Breathing, Positive End Expiratory Pressure BYE
    Laparoscope, General & Plastic Surgery GCJ
    Catheter, Cholangiography GBZ
    Airway, Oropharyngeal, Anesthesiology CAE
    Device, Fixation, Tracheal Tube CBH
    Transducer, Blood-Pressure, Extravascular DRS
    Tubing, Pressure And Accessories BYX
    Connector, Airway (Extension) BZA
    Mouthpiece, Breathing BYP
    Airway, Nasopharyngeal BTQ
    Probe, Blood-Flow, Extravascular DPT
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Injector And Syringe, Angiographic DXT
    Cannula, Nasal, Oxygen CAT
    Device, Warming. Blood And Plasma KZL
    Valve, Non-Rebreathing CBP
    Filter, Infusion Line FPB
    Manometer, Blood-Pressure, Venous KRK
    System, Thermal Regulating DWJ
    Tube, Tracheostomy (W/Wo Connector) BTO
    Nebulizer (Direct Patient Interface) CAF
    Needle, Hypodermic, Single Lumen FMI
    Stopcock, I.V. Set FMG
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
    Filter, Bacterial, Breathing-Circuit CAH
    Arterial Blood Sampling Kit CBT
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    System/Device, Pharmacy Compounding NEP
    Gauge, Measuring JYJ
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Catheter, Retention Type, Balloon EZL
    Collector, Urine, (And Accessories) For Indwelling Catheter KNX
    System, X-Ray, Tomography, Computed JAK
    Injector, Contrast Medium, Automatic IZQ
    Cuff, Tracheal Tube, Inflatable BSK
    Condenser, Heat And Moisture (Artificial Nose) BYD
    Needle, Conduction, Anesthetic (W/Wo Introducer) BSP

    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 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) 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 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 Reinforced Endotracheal Tube TranStar Jelco® Venipuncture Needle-Pro® Device Low pressure ext. tubing High pressure ext. tubing AquinOx 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 Needle-Pro Edge Medex Tubing Connectors & Stopcocks PORTEX CUFF PRESSURE GAUGE ViaValve Wing Jelco ViaValve-W Safety IV Catheter Jelco ViaValve Safety IV Catheter KidsKit (R) Secure (R) PROTECTIV Jelco Jelco-W I.V. Catheter Cathlon Optiva Jelco ProtectIV-W Safety IV Catheter Jelco ProtectIV Plus-W Safety IV Catheter Option-v PressureEasy PORTEX HYDROFLOW SUCTION IRRIGATION SYSTEM SmartSite Anesthesia stopcock Filtered HME HME THERMOVENT THERMOVENT T - 15MM CONNECTOR HEAT & MOISTURE EXCHANGER, 50/CA Microbar monitoring line filter Portex EchoGlo Peripheral Nerve Block Needle: Continuous Catheter Portex EchoGlo Peripheral Nerve Block Needle: Single Shot Portex EchoGlo Single Shot Nerve Block Support Kit Portex EchoGlo Continuous Nerve Block Kit

    Establishment Types

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