BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

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

    Reg #: 9617604 · FEI: 3002558692 · Expires 2026
    View on FDA
    Products
    58
    Proprietary Names
    274
    Establishment Types
    3
    Classifications
    58

    Registration Details

    Registration Name
    ICU Medical Healthcare Manufacturing S.A. de C.V.
    Registration Number
    9617604
    FEI Number
    3002558692
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    AVENIDA CALIDAD No 14409, Parque Industrial Internacional Tijuana
    City
    Tijuana, B.C. C.P. Baja California
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K083451

    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
    Filter, Conduction, Anesthetic BSN
    Filter, Bacterial, Breathing-Circuit CAH
    Needle, Spinal, Short Term MIA
    System, Thermal Regulating DWJ
    Port & Catheter, Implanted, Subcutaneous, Intravascular LJT
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Continuous Measurement Thermometer FLL
    Mouthpiece, Breathing BYP
    Stethoscope, Esophageal, With Electrical Conductors BZT
    Port & Catheter, Implanted, Subcutaneous, Intraperitoneal LLD
    Anesthesia Conduction Kit CAZ
    Warmer, Thermal, Infusion Fluid LGZ
    Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
    Instruments, Surgical, Cardiovascular DWS
    Set, Administration, Intravascular FPA
    Resuscitator, Manual, Non Self-Inflating NHK
    Set, Tubing And Support, Ventilator (W Harness) BZO
    Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days LJS
    Connector, Airway (Extension) BZA
    Bed, Rocking, Breathing Assist CCO
    Bag, Reservoir BTC
    Spirometer, Therapeutic (Incentive) BWF
    Tube, Tracheostomy (W/Wo Connector) BTO
    Ventilator, Emergency, Manual (Resuscitator) BTM
    Tube Tracheostomy And Tube Cuff JOH
    Warmer, Blood, Non-Electromagnetic Radiation BSB
    Tube, Tracheal (W/Wo Connector) BTR
    Stylet, Tracheal Tube BSR
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Pump, Infusion, Pca MEA
    Catheters, Suction, Tracheobronchial BSY
    Pump, Infusion, Insulin LZG
    Stethoscope, Esophageal BZW
    Support, Breathing Tube JAY
    Set, I.V. Fluid Transfer LHI
    Administrations Sets With Neuraxial Connectors PWH
    Mask, Oxygen BYG
    Needle, Hypodermic, Single Lumen FMI
    Pump, Infusion FRN
    Catheter, Conduction, Anesthetic BSO
    Introducer, Catheter DYB
    Condenser, Heat And Moisture (Artificial Nose) BYD
    Anesthesia Breathing Circuit Kit (Adult & Pediatric) OFP
    Catheter, Urological KOD
    Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) CBI
    Needle, Emergency Airway BWC
    Nebulizer (Direct Patient Interface) CAF
    Mask, Gas, Anesthetic BSJ
    Arterial Blood Sampling Kit CBT
    Brush, Cleaning, Tracheal Tube EPE
    Monitor, Airway Pressure (Includes Gauge And/Or Alarm) CAP
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Bottle, Collection, Vacuum KDQ
    Device, Warming. Blood And Plasma KZL
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass DTW
    Apparatus, Gas-Scavenging CBN
    Gas-Machine, Anesthesia BSZ

    Proprietary Names

    Portex Epidural Filter Portex HMEF HEPA Vent filter Portex Lancet Point Spinal Needles with NRFit Connectors Portex Pencil Point Spinal Needles with NRFit Connectors Snuggle Warm PORT-A-CATH GASEOUS-PHASE GAS Portex Anesthesia Airway Gas Sampling Line ANALYZER CARBON-DIOXIDE Tympanic Temperature Sensor UNIVERSAL MOUTHPIECE Esophageal Stethoscope w/thermocouple Level 1 Esophageal Stethoscope w/thermocouple Port-a-Cath Peritoneal Port PeriFuse Level 1 Hotline 2 Fluid Warming Set Hotline 2 Fluid Warmers 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 SUBCUTANEOUS TUNNELING DEVICE CADD Administration Set Port-a-Cath II Ti/Polysolfone Port Snuggle Warm® Blankets "SNUGGLE WARM" CONVE Manual Ventilator Transport Kit VALVE FILTER ASSEMBLY Portex Hyperinflation Bag System Portex Manual Ventilator Transport Kit Hyperinflation System PORT-A-CATH Power P.A.C. Implantable Venous Access Systems Thera-Heat Ohmeda VARIOUS W/WO MALE-FEMALE LUERS W/WO MALE-MALE LUERS O FILTER SMITHS GS LINES UNI-SET VENTILATOR CIRCUITS Clinicath Sheath Introducer 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 PVC - Portex Tubes Blue Line Classic CADD High Volume Administration Set CADD Extension Set RESERVOIR BAG Flo2 Anesthesia Breathing Bag Incentive Spirometer Portex Incentive Spirometer PERC TRACH KIT with Forceps PORTEX GRIGGS PERC TRACH KITS BLU BLUS 1st Response Adult Manual Resuscita PEEP Valve Exhalation filter Bivona® Aire-Cuf® Neonatal and Pediatric Tracheostomy Tubes Portex PDT Trachesotomy kit Portex Percutaneous Dilation Trachesotomy kit PAC Titanium Contoured Port Silicon PAC Titanium Contoured Port Polyure Level 1 (R) Fast Flow Fluid Warmer Medication Cassette Reservoir SACETT Suction above cuff Tracheal Tube Datascope General Purpose Probe Level 1 Esophageal/Recal Temperature Probe Novaplus Bivona Disconnect Wedge Natural, Yellow, Blue 250 ML Reservoir with FFP Bougie Introducer Portex Respiratory Stylets (IFE) Administration Set Male/Male Luer Flexible Meidication Reservior Jelco Saf-T Holder Device Saf-T Holder MULTIPLE BIVONA MULTIPLE BIVONA (IFE) CADD-Prizm PCS Infusion Pump CADD-Prizm PCS Accessories PAC II Ti/Polysulfone Port Preatchd PAC II Ti/Polysulfone Port Low Prof PORTEX TUOHY EPIDURAL NEEDLE Portex Adjustable Flange Tracheostomy Tube Bivona Bivona® Aire-Cuf® Tracheostomy Tubes Portex HEPA filters Portex HEPA/HME filters SuctionPro 72 No-Pour Neo-vac meconium Maxiflo Steri-Cath Portex Catheters Maxi-Flo (IFE) Cathmark MULTIPLE (STERICATH Polar North Polar South maxillo-facial Deltec Cozmo Insulin Pump Mdl. 1700 Deltec Cozmo 3-ml Insulin Cartridge Cozmonitor Blood Glucose Monitor PAC Ti Dual Lumen Portal Level 1 Esophageal Stethoscope Esophageal Stethoscope CADD High volume Administration Set Tracheal tube holders Portex Tube Securement Other (IFE) CADD® Yellow Medication Cassette Reservoir with NRFit™ connector Female Yellow Cap with NRFit™ connector Male Yellow Cap with NRFit™ connector CADD® Yellow Extension Sets with NRFit™ connector CADD® Yellow Administration Set with NRFit™ connector CADD® Filling Adapter with male NRFit™ connector and female Luer CADD® Infusion Adapter with male NRFit™ connector and female Luer Portex Filter Straw with NRFit Connector Portex Epidural Flat Filter with NRFit Connector Portex L.O.R. Syringes with NRFit Connector Portex EpiFuse Catheter with NRFit Connector Portex Filter Needle with NRFit Connector FaceTent Drainage Bag First Breath TrachT Bivona® Cuff Maintenance Device (CMD¿)open Portex BLUselect Tracheostomy Tube Portex BLUselect Suctionaid Tracheostomy Tube Portex BLUselect Tracheostomy Inner Cannula Gripper Needle Gripper PLUS Needle Portex Reinforced Tracheal Tube CADD-MS3 Infusion Pump Cartridge, CADD-MS3 Thermovent HEPA filters PAC Dual Lumen Portal Preconnected Portex Percutaneous Dilation Tracheostomy Kit Portex Blue Line Ultra® tracheostomy tubes Portex ULTRAperc tracheostomy apparatus and instruments PORTEX ULTRAPERC Portex Pulmonary Function Test Filt Portex Pulmonary Function Test Filter LockIt Plus EpiFuse Jelco Point-Lok Sharps Safety Device Point-Lok Neo-Therm Level 1 Skin Temperature Sensor Portex Endotracheal Tube (IFE) CLEO Infusion Set SUB-Q Infusion Set BLUperc Percutaneous Dilation Tracheostomy Procedural Kit or Tray with or without BLUselect Tracheostomy Tube BLUgriggs Percutaneous Dilation Tracheostomy Procedural Kit or Tray with BLUselect Tracheostomy Tube with or without Bivona Hyperflex Bivona Adjustable Hyperflex CSEcure® Combined Spinal Epidural Portex Filters Peel Away Sheath Introducers Filtered HME HME THERMOVENT THERMOVENT T - 15MM CONNECTOR HEAT & MOISTURE EXCHANGER, 50/CA Portex Reinforced Endotracheal Tube GRIPPER MICRO DIC LARYNGECTOMY DIC TRACHEOSTOMY TUBE Leval (1) Irrigation Accessories Portex Blue Line Endobronchial Tube Blue Line Portex Emergency Cricothyroidotomy Portex Emergency Cricothyroidotomy Kit ProPort Plastic Port Poly Cath ProPort Plastic Port Silicone Cath GRIPPER POWER PORT-A-CATH II Implantable Venous Access System POWER PORT-A-CATH Implantable Venous Access System POWER GRIPPER PLUS Needle Bivona® Uncuffed Neonatal and Pediatric FlexTend Plus Silicone Tracheostomy Tubes Portex Suction Adaptor Portex® Plastic L.O.R. Syringes PAC Dual Lumen Porta Ti/Polysulfone Level 1® H-1200 Fast Flow Fluid Warmer Bivona® Mid-Range Aire-Cuf® Adult Tracheostomy Tubes Gripper Plus PAC Implantable Power Port Blue Line Ultra Tracheostomy Tubes and Kits Portex Blue Line Ultra Tracheostomy Kit Portex Blue Line Ultra Tracheostomy Tube Portex Blue Line Ultra Tracheostomy Tube Inner Cannula Blue Line Ultra Inner Cannulas GRIPPER PLUS Needle Portex Small Volume Medication Nebulizer Portex Small Volume Medication Nebulizer Kit Medication Nebulizer Level 1 Esophageal/Rectal Temperature Probe Portex Blue Line Ultra Paediatric Tracheotomy Tube Face Mask Plus Premium Portex combined Spinal/Epidural Minipack Portex Epidural Minipack System Pencil Point Spinal Needle Portex Regional Anesthesia Catheter Connector Single Shot Epidural tray/kit Continuous Epidural tray/kit Spinal tray/kit NORMOFLO Portex NRFit Epidural Needles Jelco Saf-T Wing Blood Collection and Infusion Set Jelco Saf-T Wing Blood Collection Set Saf-T Wing PAC Dual Lumen Port, Low Profile Gripper Micro 1.25 inch Needle Access Device ProPort Plastic Preattched Catheter Equator® Convective Warmer Snuggle Warm® Convective Warming Blanket Bivona® Uncuffed Neonatal and Pediatric Tracheostomy Tubes Port-a-Cath Port Port-a-Cath Needle (various) Hotline Hotline 3 Myocardial Temperature Sensors Portex Blue Line Ultra Tracheostomy Kit Suctionaid Portex Blue Line Ultra Suctionaid Trachostomy Tube Kits BL Ultra Suctionaid Change Kits Blue Line Ultra Suctionaid Super Brush D.I.C. Tracheostomy Tubes D.I.C. Flex Tracheostomy Tubes First Response DISPOSABLE MANOMETER ANESTHESIA BREATHING CIRCUITS Modified Jackson-Rees Expandable Single Limb UniPerc Adjustable Flange Tracheostomy Tube UniPerc PDT Kit UniPerc Percutaneous Dilation Tracheostomy Kit Bivona® Fome-Cuf® Tracheostomy Tubes Level 1 Normothermic I.V. Fluid Administration Set Disposable Normothermic IV Administration Sets PAC II FluroFree Port PAC II FluroFree LP Dual Lumen Port PAC II FluroFree Low Profile Port PAS Port Elite Infusion Port Locator Wand Cover Portex®Spinal Needles HYPERINFLATION BAG SYSTEM PORTEX HYPERINFLATION BAG SYSTEM Myocardial Temperature Sensor Saf-T Wing (IFE) CADD Prizm High Vol. Admin. Set GE Datex-Ohmedla Aisys CS' Anesthesia System

    Establishment Types

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