BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ICU Medical, Inc.

    Reg #: 3012307300 · FEI: 3012307300 · Expires 2026
    View on FDA
    Products
    117
    Proprietary Names
    553
    Establishment Types
    3
    Classifications
    117

    Registration Details

    Registration Name
    ICU Medical, Inc.
    Registration Number
    3012307300
    FEI Number
    3012307300
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6000 Nathan Lane North
    City
    Minneapolis
    State
    MN
    ZIP
    55442
    Country
    US

    Regulatory Submissions

    510(k) Number
    K061513

    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

    Products

    Device Name Product Code
    System, Thermal Regulating DWJ
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Filter, Bacterial, Breathing-Circuit CAH
    Set, Administration, Intravascular FPA
    Port & Catheter, Implanted, Subcutaneous, Intravascular LJT
    Valve, Non-Rebreathing CBP
    Stylet, Tracheal Tube BSR
    Tube Tracheostomy And Tube Cuff JOH
    Pump, Infusion, Insulin LZG
    Accessories, Pump, Infusion MRZ
    Pump, Infusion FRN
    Airway, Nasopharyngeal BTQ
    Tube, Tracheal (W/Wo Connector) BTR
    Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) CBI
    Introducer, Catheter DYB
    Continuous Measurement Thermometer FLL
    Spirometer, Therapeutic (Incentive) BWF
    Nebulizer (Direct Patient Interface) CAF
    Oximeter DQA
    Anesthesia Conduction Kit CAZ
    Condenser, Heat And Moisture (Artificial Nose) BYD
    Meter, Airway Pressure (Inspiratory Force) BXR
    Tube, Tracheostomy (W/Wo Connector) BTO
    Arterial Blood Sampling Kit CBT
    Catheter, Continuous Flush KRA
    Surgeon'S Gloves KGO
    Mask, Gas, Anesthetic BSJ
    Cannula, Nasal, Oxygen CAT
    Catheter, Conduction, Anesthetic BSO
    Warmer, Thermal, Infusion Fluid LGZ
    Ventilator, Emergency, Manual (Resuscitator) BTM
    Monitor, Breathing Frequency BZQ
    Needle, Hypodermic, Single Lumen FMI
    Pump, Infusion, Pca MEA
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Transducer, Blood-Pressure, Extravascular DRS
    Container, Specimen, Sterile FMH
    Catheters, Suction, Tracheobronchial BSY
    Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
    Warmer, Blood, Non-Electromagnetic Radiation BSB
    Filter, Infusion Line FPB
    Oximeter, Ear DPZ
    Syringe, Antistick MEG
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Absorbent, Carbon-Dioxide CBL
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Mouthpiece, Breathing BYP
    Balloon, Epistaxis EMX
    Tubing, Pressure And Accessories BYX
    Medical Device Data System OUG
    Connector, Airway (Extension) BZA
    Cuff, Tracheal Tube, Inflatable BSK
    Stethoscope, Esophageal BZW
    Catheter, Urological KOD
    Resuscitator, Manual, Non Self-Inflating NHK
    Stopcock, I.V. Set FMG
    Dressing Change Tray OXQ
    Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days LJS
    Anesthesia Breathing Circuit Kit (Adult & Pediatric) OFP
    Manometer, Blood-Pressure, Venous KRK
    Injector And Syringe, Angiographic DXT
    Catheter, Percutaneous DQY
    Bottle, Collection, Vacuum KDQ
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
    Ventilator, Continuous, Facility Use CBK
    Neuraxial Administration Set - Intrathecal Delivery PYR
    Laparoscope, General & Plastic Surgery GCJ
    Ventilator, Emergency, Powered (Resuscitator) BTL
    Device, Monitoring, Intracranial Pressure GWM
    Catheter, Irrigation GBX
    Bag, Reservoir BTC
    Needle, Spinal, Short Term MIA
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    Syringe, Piston FMF
    Bed, Rocking, Breathing Assist CCO
    Splint, Extremity, Noninflatable, External, Sterile FYH
    Device, Warming. Blood And Plasma KZL
    Instruments, Surgical, Cardiovascular DWS
    System/Device, Pharmacy Compounding NEP
    Regulator, Pressure, Gas Cylinder CAN
    Monitor, Airway Pressure (Includes Gauge And/Or Alarm) CAP
    Gauge, Measuring JYJ
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Catheter, Cholangiography GBZ
    Exerciser, Non-Measuring ION
    Device, Fixation, Tracheal Tube CBH
    Percussor, Powered-Electric BYI
    Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass DTW
    Attachment, Breathing, Positive End Expiratory Pressure BYE
    Tracheotomy Care Kit NXA
    Bottle, Collection, Breathing System (Calibrated) CBD
    Stethoscope, Esophageal, With Electrical Conductors BZT
    Syringe, Balloon Inflation MAV
    Stand, Infusion FOX
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Catheter Introducer Kit OFD
    Peripheral Catheter Insertion Kit OWL
    Probe, Blood-Flow, Extravascular DPT
    Infusor, Pressure, For I.V. Bags KZD
    Catheter, Retention Type EZK
    Port & Catheter, Implanted, Subcutaneous, Intraperitoneal LLD
    Filter, Conduction, Anesthetic BSN
    Airway, Oropharyngeal, Anesthesiology CAE
    Mask, Oxygen, Non-Rebreathing KGB
    Laryngoscope, Rigid CCW
    Infusion Safety Management Software PHC
    Set, I.V. Fluid Transfer LHI
    Administrations Sets With Neuraxial Connectors PWH
    Device, Cystometric, Hydraulic FEN
    Cardiograph, Apex (Vibrocardiograph) DQH
    Catheter, Intravascular, Diagnostic DQO
    Mask, Oxygen, Low Concentration, Venturi BYF
    Mask, Oxygen BYG
    Needle, Emergency Airway BWC
    Set, Tubing And Support, Ventilator (W Harness) BZO
    Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
    Support, Breathing Tube JAY

    Proprietary Names

    Snuggle Warm Airway adaptor Portex Pulmonary Function Test Filt Portex Pulmonary Function Test Filter Gripper Plus PAC Implantable Power Port Safe-Response Portex Bougie Introducer Portex Respiratory Stylets (IFE) GASEOUS-PHASE GAS Portex Anesthesia Airway Gas Sampling Line ANALYZER CARBON-DIOXIDE Trifurcated IV set ProPort Plastic Port Poly Cath ProPort Plastic Port Silicone Cath CozManager 2 Cozmo Insulin Pump Mdl. 1800 CADD-Solis MSS Software LockBox for Solis Pump (accessory) Portex Airway Nasopharyngeal (IFE) PharmGuard Tool Box D.I.C. Tracheostomy Tubes D.I.C. Flex Tracheostomy Tubes Nebulizer Filter Portex Blue Line Endobronchial Tube Blue Line CADD-Prizm VIP Pump CADD-Prizm VIP Pump Accessories Neo-Therm Level 1 Skin Temperature Sensor DHD Cliniflo® Low Flow Exerciser DHD CliniFlo EASIVENT Myocardial Temperature Sensors BCI PeriFuse Filtered HME HME THERMOVENT THERMOVENT T - 15MM CONNECTOR HEAT & MOISTURE EXCHANGER, 50/CA NIF-TEE NIF KIT RESCAL Portex Percutaneous Dilation Tracheostomy Kit Portex Blue Line Ultra® tracheostomy tubes Portex ULTRAperc tracheostomy apparatus and instruments PORTEX ULTRAPERC EpiFuse Coach 2 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 Portex Endotracheal Tube (IFE) Port-a-Cath II Ti/Polysolfone Port Point-Lok ACAPELLA CHOICE DH DUET DM AEROPHARM HemoDraw Medex Trigger Flush Device Portex Central Line Dressing Natural, Yellow, Blue 250 ML Reservoir with FFP Face Mask Plus Premium Bivona® Fome-Cuf® Tracheostomy Tubes AquinOx First Breath Portex Nasal Oxygen set (IFE) OXYGEN NASAL CANNULA LockIt Plus Nasal Cannula Bivona Sleep Apnea Tracheostomy Tube HMEF HEPA Vent filter Hotline 2 Hotline Pediatric Manual Resuscitator- Infant Manual Resuscitator Pediatric O2 Nasal Cannula EzPAP Jelco® Hypodermic Needle-Pro® EDGE¿ Safety Device Equator® Convective Warmer Snuggle Warm® Convective Warming Blanket Bivona® Fome-Cuf® Adult Tracheostomy Tubes with Talk Attachment Administration Set Male/Male Luer Flexible Meidication Reservior CADD-Legacy AC Adapter CADD-Legacy Polemount Bracket CADD-Legacy Battery Door CADD-Legacy Reusabel Pouch CADD-Legacy Single Use Pouches CADD-Legacy Remote Dose Cord CADD-Legacy PCA Pump Mld 6300 IV Pump Admin Sets (Filtered) Medfusion Model 2010 Medication Cassette Reservoir Portex Reinforced Tracheal Tube Jelco Saf-T Holder Device Saf-T Holder HemoDraw® Plus Closed Blood Sampling System with LogiCal® Transducer System TranStar® Pressure Monitoring System 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 Portex Specimen Trap Snuggle Warm® Blankets "SNUGGLE WARM" CONVE Portex Suction Adaptor Stealth Portex NRFit Epidural Needles Fluid Warmer Mouth To Mask Resuscitator SACETT Suction above cuff Tracheal Tube Bivona® Uncuffed Neonatal and Pediatric FlexTend Plus Silicone Tracheostomy Tubes KidsKit (R) Secure (R) IV Filter sets HemoDraw Plus Closed Blood Sampling Set with LogiCal Transducer System HemoDraw Plus Closed Blood Sampling Set with TranStar Transducer System Needle-Pro Edge Travel Case, Cozmo Pump Pump Pouch, Cozmo Pump Belt Clip, Cozmo Pump Ir Adapter, Cozmo Pump Portex PDT Trachesotomy kit Portex Percutaneous Dilation Trachesotomy kit 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 PAC Dual Lumen Porta Ti/Polysulfone CADD Administration Set Hand-Held 3303 Pulse Oximeter BCI 3301 Hand-Held Oximeter Spectro2/20 Pulse Oximeter Jelco® Hypodermic Needle-Pro® EDGE¿ Safety Device with Syringe NIBP Cuff Set Infant Wrap Sensor Neonate Wrap Sensor CADD-Solis Mdl 2110 Replacement Door (accessory) AC Adapter (accessory) CADD-Solis, Mdl 2100 Infusion Pump Remote Dose Cord (accessory) Battery Pack (accessory) Polemount Bracket (accessory) PAC Dual Lumen Portal Preconnected CADD®-Solis VIP Ambulatory Infusion System Jelco Saf-T Wing Blood Collection and Infusion Set Jelco Saf-T Wing Blood Collection Set Saf-T Wing Sodasorb Portex Small Volume Medication Nebulizer Portex Small Volume Medication Nebulizer Kit Medication Nebulizer Bivona® Mid-Range Aire-Cuf® Adult Tracheostomy Tubes PROTECTIV Jelco Jelco-W I.V. Catheter Cathlon Optiva Jelco ProtectIV-W Safety IV Catheter Jelco ProtectIV Plus-W Safety IV Catheter Remote Dose Cord UNIVERSAL MOUTHPIECE Medex Various IV administration sets Epistaxis catheter Blue Line Manometer Connecting Tube (IFE) OXYGEN TUBING Pharmguard ToolBox CADD-Legacy 1 Pump Mdl 6400 Contrast Control Device Contrast Manager Thera-Mist Spectro2/30 Pulse Oximeter BIVONA Ultraset Mount Adapter Duralife Portex Oxygen/Aerosol Adapters and Connectors (IFE) Portex Oxygen/Aerosol Tubing (IFE) Industrial - Connectors (IFE) Connector Portex Fibre-Optic Bronchoscope Swivel Connector (IFE) Swivel Elbow CIRCUVENT GRIPPER PLUS Needle Miniloop PressureEasy Level 1 Esophageal Stethoscope Esophageal Stethoscope MiniTorr NIBP MULTIPLE BIVONA Bivona Hyperflex Bivona Adjustable Hyperflex Thermovent Medfusion ACE Leval (1) Irrigation Accessories Bivona® Aire-Cuf® Neonatal and Pediatric Tracheostomy Tubes HYPERINFLATION BAG SYSTEM PORTEX HYPERINFLATION BAG SYSTEM PERC TRACH KIT with Forceps PORTEX GRIGGS PERC TRACH KITS BLU BLUS Pulsator Pro-Vent Line Draw MEDEX STOPCOCK & LUER LOCK PLUG Clinicath Sheath Introducer SuctionPro 72 No-Pour Neo-vac meconium Maxiflo Steri-Cath Portex Catheters Maxi-Flo (IFE) Cathmark MULTIPLE (STERICATH Deltec 3000 CADD Extension Set Jelco Point-Lok Sharps Safety Device Per-fit Medex Central Venous Pressure Manometer PAC II FluroFree Port PAC II FluroFree LP Dual Lumen Port PAC II FluroFree Low Profile Port CADD High volume Administration Set External Power Source, Infusn Pump Replacement Accessories Bivona® Cuff Maintenance Device (CMD¿)open PAC Dual Lumen Port, Low Profile Nu-site SmartSite Low pressure ext. tubing High pressure ext. tubing Spectro2/10 Pulse Oximeter Hotline 3 Ohmeda Hemostatic Y various adapters and connectors TheraPEP Pediatric Disposable Breathing Circuit Pneupac babyPAC Ventilator Kit PORTEX TUOHY EPIDURAL NEEDLE Wireless Communication Module (CM) PharmGuard Administrator Medication Safety Software CADD-Solis Ambulatory Infusion Pump CADD-Administration Sets Small Bore Stopcocks PORTEX HYDROFLOW SUCTION IRRIGATION SYSTEM Pneupac paraPAC with electronic alarms TranStar (R) PAC II Ti/Polysulfone Port Preatchd PAC II Ti/Polysulfone Port Low Prof Minicorr Digital Hand-Held Pulse Oximeter ViaValve Jelco ViaValve Safety IV Catheter Resuscitation Valve Assembly with Filter Portex Reinforced Endotracheal Tube CADD-Prizm PCS II Pump Mdl 6101 Bi-Temp Temperatur Probe Graseby Micro 3100 Volumetric Infusion Pump Graseby Model 3000 Volumetric Infusion Pump Advisor Vital Signs Monitor Level 1 Hotline 2 Fluid Warming Set Hotline 2 Fluid Warmers PEDIPLUS MANUAL RESUSCITATOR CADD-MS3 Infusion Pump Cartridge, CADD-MS3 Foley Catheter Temperature Sensor Portex Hydrophobic Tubing Filter Portex Hydrophilic Filters CADD-Prizm PCS Infusion Pump CADD High Volume Administration Set CADD-Prizm PCS Accessories Bivona® Aire-Cuf® Tracheostomy Tubes Saf-T Wing (IFE) ProPort Plastic Preattched Catheter Mouth To Mask Resuscitator-child First Response 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) Needle-Pro Oximeter RESERVOIR BAG Flo2 Anesthesia Breathing Bag Portex®Spinal Needles Deltec Cozmo Insulin Pump Mdl. 1700 Deltec Cozmo 3-ml Insulin Cartridge Cozmonitor Blood Glucose Monitor Portex Blue Line Ultra Paediatric Tracheotomy Tube IV admin set with minicheck valve PORT-A-CATH Power P.A.C. Implantable Venous Access Systems BCI Autocorr Portex Filters LogiCal(R) GRIPPER MICRO CADD Prizm High Vol. Admin. Set Flex D.I.C Tracheostomy Tube Portex Hydroflow Probes DIC LARYNGECTOMY DIC TRACHEOSTOMY TUBE Pneupac babyPAC Peel Away Sheath Introducers Aerogard Aeromist Jelco® Hypodermic Needle-Pro® Device for Insulin Injections Lo-Profile Tracheostomy Tubes PVC - Portex Tubes Blue Line Classic Level 1 Convective Warmer 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 Portex Adjustable Flange Tracheostomy Tube MULTIPLE BIVONA (IFE) Lock Box and Accessories Jelco Cradle 1-Liter & 3-Liter Pump Pouch H-2 Pressure Cuff Tympanic Temperature Sensor Bivona Disconnect Wedge Level 1 Normothermic I.V. Fluid Administration Set Disposable Normothermic IV Administration Sets SUBCUTANEOUS TUNNELING DEVICE 400 Series Cables Medex Tubing Connectors & Stopcocks injection adapter Oximeter Ear Probe Finger Probe PRESSURE REGULATOR GAS CYLINDER TUBING CONNECTOR (OXYGEN FLOWMETER REGULATOR CONNECTOR) DISPOSABLE MANOMETER Level 1 Esophageal/Rectal Temperature Probe General Purpose Probe Incentive Spirometer Portex Incentive Spirometer PORTEX CUFF PRESSURE GAUGE humidification chambers Capnocheck BCI 9200 Vital Signs Monitor Pneupac VR1 Airmix Level 1 (R) Fast Flow Fluid Warmer Portex Cholangiogram Buchanan Cannulas (IFE) CorrectInject EXERCISER INSPIRATORY MUSCLE TRAINER KIT CADD® - Solis Ambulatory Pump, Model 3 CADD® - Solis Medication Safety Software, Version 3.1 Gripper Micro 1.25 inch Needle Access Device Level 1® H-1200 Fast Flow Fluid Warmer Jelco® Venipuncture Needle-Pro® Device DHD LONG TERM ENDOT SECUREEASY PALM CUP PERCUSSOR Portex Flo-Mist Manual Ventilator Transport Kit VALVE FILTER ASSEMBLY Portex Hyperinflation Bag System Portex Manual Ventilator Transport Kit Hyperinflation System Portex® Plastic L.O.R. Syringes Myocardial Temperature Sensor Capnograph Portex BLUselect Tracheostomy Tube Portex BLUselect Suctionaid Tracheostomy Tube Portex BLUselect Tracheostomy Inner Cannula Pneupac paraPAC plus Disposable CPAP Circuit Pneupac paraPAC plus CADD-Ambassador Pump Com Sys CADD-Sentry Medication Safety Softw CADD-Diplomat PC System CADD-Prizm IR Adapter Portex Tracheostomy Care Kits Datascope Level 1 Esophageal/Recal Temperature Probe Novaplus Pneupac VR1 Standard Pneupac VR1 Responder VACON Digit Finger Pulse Oximeter Esophageal Stethoscope w/thermocouple Level 1 Esophageal Stethoscope w/thermocouple CLEO Infusion Set SUB-Q Infusion Set Medflator II various clamps and brackets ANESTHESIA BREATHING CIRCUITS Modified Jackson-Rees Expandable Single Limb NORMOFLO TranStar Hand-Held Pulse Oximeter CLEAR CUFF C-FUSOR LogiCal (R) Novadome Novatrans Transstar FingerPrint Hand-Held Pulse Oximeter UniPerc Adjustable Flange Tracheostomy Tube UniPerc PDT Kit UniPerc Percutaneous Dilation Tracheostomy Kit Urine Meter Foley Tray Portex HEPA filters Portex HEPA/HME filters Spectro2/Logix Clinical Access Software Port-a-Cath Peritoneal Port Acuvance Acuvance Jelco Safety IV Catheter AutoCorr Plus MULTIPLE BIVONA ENDOTRACHEAL Bivona® Uncuffed Neonatal and Pediatric Tracheostomy Tubes Microbar monitoring line filter Portex Epidural Filter Portex Single Use Airways (IFE) Laryngeal Mask Portex Airway Guedel Oropharyngeal (IFE) Guedel Berman AIREASY OROPHARYNGEAL NovaTrans(R) PORT-A-CATH NON-REBREATHING MASK Pharmguard Tool Box Medfusion 4000 Adult oral/Nasal CO2 Sample Line PAS Port Elite Infusion Port Locator Wand Cover Blood transfer device CADD-Legacy Plus Pump Mdl 6500 Medex Bacterial Filter AsthmaKit LockBox Medfusion 3000 Series Pumps Europa Lunar Callisto Optima Macintosh Miller Mini-vol extension set CSEcure® Combined Spinal Epidural Thermovent HEPA filters Polar North Polar South maxillo-facial PAC Ti Dual Lumen Portal Portex Blue Line Ultra Tracheostomy Kit Suctionaid Portex Blue Line Ultra Suctionaid Trachostomy Tube Kits BL Ultra Suctionaid Change Kits Blue Line Ultra Suctionaid SmartSite Anesthesia stopcock Gauge Guard BREATHING-CIRCUIT BACTERIAL FILTER FingerPrint Sleep Hand-Held Pulse Oximeter 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 Volumetric Administration Sets ViaValve Wing Jelco ViaValve-W Safety IV Catheter SmartSite T- Connector 1st Response Adult Manual Resuscita PEEP Valve Exhalation filter PAC Titanium Contoured Port Silicon PAC Titanium Contoured Port Polyure Port-a-Cath Port Port-a-Cath Needle (various) EDGE MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER VERSION 2 Sleep Capnograph GRIPPER POWER PORT-A-CATH II Implantable Venous Access System POWER PORT-A-CATH Implantable Venous Access System POWER GRIPPER PLUS Needle 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 Filter-Pro Comfort Clip® Finger Sensor 3180 Pulse Oximeter OXYPEEP FLO2 First breath FaceTent Drainage Bag TrachT Portex Mini-Trach II Portex Emergency Cricothyroidotomy Portex Emergency Cricothyroidotomy Kit FACEPLATE AIRCARE® Thera-Heat VARIOUS W/WO MALE-FEMALE LUERS W/WO MALE-MALE LUERS O FILTER SMITHS GS LINES UNI-SET VENTILATOR CIRCUITS Penupac ventiPAC with electronic alarms Medfusion Infusion Pump 3000 series NormoFlo® Irrigating System Tracheal tube holders Portex Tube Securement Other (IFE) Gripper Needle Gripper PLUS Needle Bivona paraPAC Capnocheck Oximeter Capnocheck II Hand-Held Portex Lancet Point Spinal Needles with NRFit Connectors Portex Pencil Point Spinal Needles with NRFit Connectors Rotating Pole Clamp Serial Conversion Box 3000 Series PVC - Portex Speaking Orator

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device