Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012307300

FEI Number

3012307300

Entity Name

ICU Medical, Inc.

City/State/Country

Minneapolis, MN, US

Establishment Address

6000 Nathan Lane North, Minneapolis, MN 55442, US

Establishment Type(s)

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

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

K980714

PMA Number

N/A

All Registered 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 Portex 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) Portex PharmGuard Tool Box D.I.C. Tracheostomy Tubes D.I.C. Flex Tracheostomy Tubes Portex Nebulizer Filter Portex 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 Portex 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 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 Snuggle Warm Portex AquinOx First Breath Portex Nasal Oxygen set (IFE) OXYGEN NASAL CANNULA LockIt Plus Nasal Cannula Bivona Sleep Apnea Tracheostomy Tube Portex 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 CADD Administration Set Remote Dose Cord UNIVERSAL MOUTHPIECE Medex Various IV administration sets Epistaxis catheter Blue Line Manometer Connecting Tube (IFE) First Breath 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 RESCAL Portex Fibre-Optic Bronchoscope Swivel Connector (IFE) Swivel Elbow CIRCUVENT GRIPPER PLUS Needle Miniloop PressureEasy CADD Administration Set 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 Snuggle Warm PERC TRACH KIT with Forceps PORTEX GRIGGS PERC TRACH KITS BLU BLUS Pulsator Pro-Vent Line Draw MEDEX STOPCOCK & LUER LOCK PLUG CADD Administration Set Clinicath Sheath Introducer SuctionPro 72 No-Pour Neo-vac meconium Maxiflo Steri-Cath Portex Portex Catheters Maxi-Flo (IFE) Cathmark MULTIPLE (STERICATH Deltec 3000 CADD Extension Set CADD Administration Set Jelco Point-Lok Sharps Safety Device Point-Lok Portex Per-fit Medex Central Venous Pressure Manometer Administration Set Male/Male Luer Portex Thera-Mist PAC II FluroFree Port PAC II FluroFree LP Dual Lumen Port PAC II FluroFree Low Profile Port CADD High volume Administration Set CADD 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 Hotline 3 Portex 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 THERMOVENT Steri-Cath 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 Safe-Response Portex Resuscitation Valve Assembly with Filter Portex Reinforced Endotracheal Tube CADD-Prizm PCS II Pump Mdl 6101 Airway adaptor Bi-Temp Temperatur Probe Saf-T Wing 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 Portex Pulsator Bivona® Aire-Cuf® Tracheostomy Tubes Saf-T Wing 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 Thera-Mist Flex D.I.C Tracheostomy Tube Portex Hydroflow Probes DIC LARYNGECTOMY DIC TRACHEOSTOMY TUBE Pneupac babyPAC Peel Away Sheath Introducers Aerogard Aeromist Thera-Mist 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 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) Portex First Response DISPOSABLE MANOMETER Level 1 Esophageal/Rectal Temperature Probe General Purpose Probe Incentive Spirometer Portex 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) Portex 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 BIVONA SECUREEASY PALM CUP PERCUSSOR Portex Flo-Mist Needle-Pro 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 General Purpose Probe Level 1 Esophageal/Recal Temperature Probe Novaplus Pneupac VR1 Standard Pneupac VR1 Responder Medication Cassette Reservoir 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 Portex NORMOFLO TranStar Hand-Held Pulse Oximeter CLEAR CUFF C-FUSOR LogiCal (R) Novadome Novatrans Transstar FingerPrint Hand-Held Pulse Oximeter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2007-12-28
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2013-01-11
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2007-12-04
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-01-07
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-01-07
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2007-12-28
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2004-07-19
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2006-06-29
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-11-28
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2021-12-10
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-02-26
LZG	Pump, Infusion, Insulin	General Hospital	Class 2	880.5725	2008-02-25
MRZ	Accessories, Pump, Infusion	General Hospital	Class 2	880.5725	2009-01-26
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2008-06-21
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	1993-01-13
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2008-02-27
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2007-12-04
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2007-12-04
CBI	Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)	Anesthesiology	Class 2	868.5740	2007-12-28
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2020-07-08
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2008-02-25
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2007-12-28
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	Class 2	868.5690	2007-12-20
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2007-12-20
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2007-12-28
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2012-03-08
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2012-09-10
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2004-07-22
BXR	Meter, Airway Pressure (Inspiratory Force)	Anesthesiology	Class 2	868.1780	2007-08-13
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2007-06-06
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2010-02-08
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	Class 2	868.5690	2007-12-20
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2018-11-09
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2018-11-09
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2008-01-05
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-02-26
CBT	Arterial Blood Sampling Kit	Anesthesiology	Class 1	868.1100	2009-12-17
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	Class 2	868.5690	2007-08-13
CBT	Arterial Blood Sampling Kit	Anesthesiology	Class 1	868.1100	2007-11-28
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2007-11-28
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2012-11-01
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-07-29
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2003-09-15
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2008-06-20
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2007-12-28
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2003-09-15
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2007-12-19
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2013-01-11
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2008-06-20
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2011-05-11
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2012-11-30
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2007-12-04
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2013-01-11
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	Class 2	868.5690	2007-12-20
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	1993-01-13
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2015-02-16
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2008-06-20
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-01-07
MEA	Pump, Infusion, Pca	General Hospital	Class 2	880.5725	2008-02-27
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-02-27
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2013-01-11
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2020-06-24
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-01-07
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2007-12-04
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2007-12-19
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2017-11-16
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	1993-01-13
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	1993-01-13
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	1994-06-29
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2007-03-06
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2012-03-08
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2018-07-27
BSB	Warmer, Blood, Non-Electromagnetic Radiation	Hematology	Class 2	864.9205	2012-11-30
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2007-12-04
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2008-07-23
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2008-06-20
CBT	Arterial Blood Sampling Kit	Anesthesiology	Class 1	868.1100	2007-11-28
FPB	Filter, Infusion Line	General Hospital	Class 2	880.5440	2007-11-28
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2020-06-24
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2017-08-16
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2007-12-21
LZG	Pump, Infusion, Insulin	General Hospital	Class 2	880.5725	2008-02-25
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2007-06-06
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2018-02-08
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-02-27
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-01-07
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2013-01-11
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2008-01-27
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2009-05-15
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2009-05-15
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2020-07-08
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2007-01-04
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2008-01-27
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2014-07-12
MEA	Pump, Infusion, Pca	General Hospital	Class 2	880.5725	2008-06-21
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-02-27
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2013-02-07
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2007-12-19
CBL	Absorbent, Carbon-Dioxide	Anesthesiology	Class 1	868.5300	2009-05-21
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2007-12-06
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2008-06-20
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2007-11-28
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-01-07
MEA	Pump, Infusion, Pca	General Hospital	Class 2	880.5725	2005-09-08
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2003-09-15
FPB	Filter, Infusion Line	General Hospital	Class 2	880.5440	2007-11-28
EMX	Balloon, Epistaxis	Ear, Nose, Throat	Class 1	874.4100	1992-06-25
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2003-09-15
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2013-01-11
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2008-02-27
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-11-28
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2007-12-20
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2009-05-15
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	1992-10-02
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2008-01-07
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-01-07
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-11-28
BSK	Cuff, Tracheal Tube, Inflatable	Anesthesiology	Class 2	868.5750	2007-12-17
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-01-07
BZW	Stethoscope, Esophageal	Anesthesiology	Class 1	868.1910	2007-12-28
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2008-01-27
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2008-01-27
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2007-11-30
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2008-11-18
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2018-09-07
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2014-11-03
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2007-12-20
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2007-12-28
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2008-06-20
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2020-06-24
NHK	Resuscitator, Manual, Non Self-Inflating	Anesthesiology	Class 2	868.5905	2007-12-06
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2009-06-08
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2007-12-04
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2007-12-19
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2020-02-27
OXQ	Dressing Change Tray	General Hospital	Class 1	880.5075	2020-06-24
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-01-07
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2008-02-26
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2006-11-08
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2014-11-03
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-01-07
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2007-12-27
OFP	Anesthesia Breathing Circuit Kit (Adult & Pediatric)	Anesthesiology	Class 1	868.5240	2020-08-04
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2007-12-28
KRK	Manometer, Blood-Pressure, Venous	Cardiovascular	Class 2	870.1140	2007-11-28
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-02-27
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2007-12-19
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2007-12-20
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2008-02-26
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-01-07
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2008-02-26
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2008-06-20
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-02-27
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-11-28
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2010-07-27
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2020-06-24
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2020-06-24
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2009-05-15
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2009-05-15
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2007-12-28
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	1992-07-20
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2007-11-28
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	Class 2	868.5690	2007-12-20
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2013-01-11
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2014-12-30
MRZ	Accessories, Pump, Infusion	General Hospital	Class 2	880.5725	2017-08-30
MEA	Pump, Infusion, Pca	General Hospital	Class 2	880.5725	2017-08-30
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-08-30
PYR	Neuraxial Administration Set - Intrathecal Delivery	General Hospital	Class 2	880.5440	2017-08-30
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2007-05-14
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2007-12-28
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2007-12-19
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2020-02-28
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	1980-01-07
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2007-11-28
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-02-26
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2008-01-27
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2012-08-10
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2007-12-28
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2007-12-04
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2008-02-27
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2013-01-11
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2007-12-28
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-12-28
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2007-12-04
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2008-01-27
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2007-12-28
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2007-12-04
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2008-01-07
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2007-12-28
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2007-12-04
MEA	Pump, Infusion, Pca	General Hospital	Class 2	880.5725	2008-01-07
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2021-07-14
CBT	Arterial Blood Sampling Kit	Anesthesiology	Class 1	868.1100	2009-12-17
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2008-06-20
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2008-08-25
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-02-26
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2007-12-04
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	Class 2	868.5690	2020-01-09
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2009-11-26
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2007-12-19
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2016-01-26
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2003-09-15
MIA	Needle, Spinal, Short Term	Anesthesiology	Class 2	868.5150	2007-01-04
LZG	Pump, Infusion, Insulin	General Hospital	Class 2	880.5725	2008-01-07
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2018-02-09
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-11-28
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2010-10-24
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2008-01-27
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2007-12-04
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2007-11-28
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-01-07
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2008-01-07
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-01-07
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2007-12-20
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2007-12-04
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2018-12-21
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2007-03-06
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2007-12-04
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2012-05-31
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2007-11-28
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2007-12-20
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	1993-01-13
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2020-06-24
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2007-12-04
CCO	Bed, Rocking, Breathing Assist	Anesthesiology	Class 2	868.5180	2018-07-24
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2018-08-14
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2007-12-04
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2008-01-03
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2007-11-30
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2008-02-25
FYH	Splint, Extremity, Noninflatable, External, Sterile	General, Plastic Surgery	Class 1	878.3910	2020-01-28
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2008-02-26
KZL	Device, Warming. Blood And Plasma	Hematology	Class 2	864.9205	2012-11-30
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2007-12-28
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2008-06-20
KZL	Device, Warming. Blood And Plasma	Hematology	Class 2	864.9205	2007-12-28
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2005-02-18
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2007-12-28
NEP	System/Device, Pharmacy Compounding	General Hospital	Class 2	880.5440	2020-05-06
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-11-28
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2007-12-06
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2007-08-13
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Anesthesiology	Class 2	868.2600	1992-10-02
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2007-12-28
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	Class 2	868.5690	2007-12-21
JYJ	Gauge, Measuring	Ear, Nose, Throat	Class 1	874.4420	1998-01-07
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2007-11-28
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2008-01-27
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2013-01-11
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2007-12-04
BSB	Warmer, Blood, Non-Electromagnetic Radiation	Hematology	Class 2	864.9205	2007-12-28
GBZ	Catheter, Cholangiography	General, Plastic Surgery	Class 1	878.4200	2018-12-21
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2012-09-20
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2007-08-13
MEA	Pump, Infusion, Pca	General Hospital	Class 2	880.5725	2014-01-24
MRZ	Accessories, Pump, Infusion	General Hospital	Class 2	880.5725	2014-01-24
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2010-10-24
BSB	Warmer, Blood, Non-Electromagnetic Radiation	Hematology	Class 2	864.9205	2007-12-28
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2007-12-19
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2003-09-15
BYI	Percussor, Powered-Electric	Anesthesiology	Class 2	868.5665	2007-08-13
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2020-06-24
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2007-12-20
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2007-12-19
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2021-10-07
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-10-07
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2021-10-07
NHK	Resuscitator, Manual, Non Self-Inflating	Anesthesiology	Class 2	868.5905	2007-12-06
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2007-12-19
DTW	Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4340	2007-12-28
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2008-01-27
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2018-11-09
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
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2008-02-26
NXA	Tracheotomy Care Kit	Anesthesiology	Class 2	868.5800	2020-03-02
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2007-12-28
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2007-12-04
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2007-03-06
CBD	Bottle, Collection, Breathing System (Calibrated)	General Hospital	Class 2	880.6740	2007-01-04
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2007-12-06
BZT	Stethoscope, Esophageal, With Electrical Conductors	Anesthesiology	Class 2	868.1920	2007-12-28
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-01-07
MAV	Syringe, Balloon Inflation	Cardiovascular	Class 2	870.1650	2007-11-28
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2008-06-02
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2007-03-06
OFD	Catheter Introducer Kit	Cardiovascular	Class 2	870.1340	2020-06-24
OWL	Peripheral Catheter Insertion Kit	General Hospital	Class 2	880.5200	2020-06-24
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2008-07-08
DPT	Probe, Blood-Flow, Extravascular	Cardiovascular	Class 2	870.2120	2008-03-03
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2008-01-27
KZD	Infusor, Pressure, For I.V. Bags	General Hospital	Class 1	880.5420	2002-02-18
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2007-11-28
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2008-01-27

Official Correspondent

Michelle Doherty

US Agent Details

No US Agent registered (Local establishment).

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

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K142467	Abeon Medical Corporation	IntelAir Nasal Airway Support System	2014-11-24
K861213	Datex Division Instrumentarium Corp.	PB 254 IR - SPECTROMETER	1986-04-04
K172904	Philips Medizin Systeme Boeblingen GmbH	IntelliVue Capnography Extension, IntelliVue Microstream Extension	2017-12-26

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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-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24
Z-0014-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24
Z-0015-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP
Z-0016-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JP
Z-0017-2025	Smiths Medical ASD Inc.	2	ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28
Z-0018-2025	Smiths Medical ASD Inc.	2	ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28

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9617604	ICU Medical Healthcare Manufacturing S.A. de C.V.	Tijuana, B.C. C.P. Baja California, MX
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3012315097	CARE ESSENTIALS INTERNATIONAL PVT LTD.	Ahmedabad Gujarat, IN
9680284	3M EDUMEX, S.A DE C.V	CD. JUAREZ Chihuahua, MX
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012307300. Last updated year: 2026. Please use registration number 3012307300 when referencing this establishment in official correspondence.