Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9617604

FEI Number

3002558692

Entity Name

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

City/State/Country

Tijuana, B.C. C.P. Baja California, MX

Establishment Address

AVENIDA CALIDAD No 14409, Parque Industrial Internacional Tijuana, Tijuana, B.C. C.P. Baja California 22424, MX

Establishment Type(s)

Manufacture Medical Device

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

K974471

PMA Number

N/A

All Registered 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 Portex Incentive Spirometer PERC TRACH KIT with Forceps PORTEX GRIGGS PERC TRACH KITS BLU BLUS Portex 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 CADD Extension Set PAC Titanium Contoured Port Silicon PAC Titanium Contoured Port Polyure Esophageal Stethoscope w/thermocouple Level 1 Esophageal Stethoscope w/thermocouple 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 Portex 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 High Volume Administration Set CADD-Prizm PCS Accessories PAC II Ti/Polysulfone Port Preatchd PAC II Ti/Polysulfone Port Low Prof PORTEX TUOHY EPIDURAL NEEDLE Snuggle Warm 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 Portex Catheters Maxi-Flo (IFE) Cathmark MULTIPLE (STERICATH Portex 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 CADD Administration Set Tracheal tube holders Portex 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 CADD Administration Set 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 CADD Administration Set Jelco Point-Lok Sharps Safety Device Point-Lok Neo-Therm Level 1 Skin Temperature Sensor Portex 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 Portex CADD Administration Set Administration Set Male/Male Luer Filtered HME Portex 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 Portex Blue Line Endobronchial Tube Blue Line Portex Emergency Cricothyroidotomy Portex Emergency Cricothyroidotomy Kit Snuggle Warm 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 PORT-A-CATH 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 CADD Extension Set CADD Administration Set 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 Steri-Cath GRIPPER PLUS Needle Portex Small Volume Medication Nebulizer Portex Small Volume Medication Nebulizer Kit Medication Nebulizer Level 1 Esophageal/Rectal Temperature Probe General Purpose Probe Portex Blue Line Ultra Paediatric Tracheotomy Tube Face Mask Plus Premium EpiFuse 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 THERMOVENT 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BSN	Filter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5130	2009-03-19
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2011-05-11
MIA	Needle, Spinal, Short Term	Anesthesiology	Class 2	868.5150	2018-07-27
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2009-06-08
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2013-01-11
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2006-06-29
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2007-12-28
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2003-09-15
BZT	Stethoscope, Esophageal, With Electrical Conductors	Anesthesiology	Class 2	868.1920	2007-12-28
LLD	Port & Catheter, Implanted, Subcutaneous, Intraperitoneal	General Hospital	Class 2	880.5965	2008-02-25
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2012-09-10
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2007-12-28
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2018-02-08
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2005-02-18
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	2008-02-26
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	1994-06-29
NHK	Resuscitator, Manual, Non Self-Inflating	Anesthesiology	Class 2	868.5905	2007-12-06
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2010-10-24
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2005-06-30
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2008-02-26
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	1992-10-02
CCO	Bed, Rocking, Breathing Assist	Anesthesiology	Class 2	868.5180	2018-07-24
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-01-07
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2003-09-15
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	Class 2	868.5690	2007-12-21
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2007-12-04
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2007-12-04
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2008-06-20
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2007-06-06
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	2008-02-26
BZT	Stethoscope, Esophageal, With Electrical Conductors	Anesthesiology	Class 2	868.1920	2007-12-28
BSB	Warmer, Blood, Non-Electromagnetic Radiation	Hematology	Class 2	864.9205	2007-12-28
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-01-07
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2008-07-23
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
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-07-29
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2004-07-19
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-01-07
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2007-12-19
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2007-11-30
MEA	Pump, Infusion, Pca	General Hospital	Class 2	880.5725	2008-01-07
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-02-26
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2014-12-30
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2007-12-28
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	2009-12-17
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2008-06-20
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2007-12-04
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2006-11-08
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	1992-10-02
LZG	Pump, Infusion, Insulin	General Hospital	Class 2	880.5725	2008-01-07
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-02-27
BZW	Stethoscope, Esophageal	Anesthesiology	Class 1	868.1910	2007-12-28
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-01-07
JAY	Support, Breathing Tube	Anesthesiology	Class 1	868.5280	2003-09-15
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2017-09-13
PWH	Administrations Sets With Neuraxial Connectors	General Hospital	Class 2	880.5440	2017-09-13
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2018-08-15
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2018-08-15
BSN	Filter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5130	2018-08-15
MIA	Needle, Spinal, Short Term	Anesthesiology	Class 2	868.5150	2018-08-15
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2003-09-15
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2008-06-20
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2018-11-09
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-03-06
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2007-03-06
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2007-12-04
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2008-01-07
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2021-07-14
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2007-12-04
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-02-27
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2007-06-06
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2007-12-04
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2007-12-19
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2008-03-05
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
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2007-12-28
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2008-01-05
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-01-07
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
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2008-11-18
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	1993-01-13
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2007-12-04
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2012-05-31
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	1993-01-13
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-01-07
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-02-27
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2021-12-10
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2004-07-22
OFP	Anesthesia Breathing Circuit Kit (Adult & Pediatric)	Anesthesiology	Class 1	868.5240	2020-08-04
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2007-12-04
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
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2007-03-06
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2007-12-28
CBI	Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)	Anesthesiology	Class 2	868.5740	2007-12-28
BWC	Needle, Emergency Airway	Anesthesiology	Class 2	868.5090	2010-04-07
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2007-12-28
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-02-26
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2012-09-27
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2012-09-27
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2008-06-20
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2007-03-06
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2007-12-19
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-02-27
BSB	Warmer, Blood, Non-Electromagnetic Radiation	Hematology	Class 2	864.9205	2007-12-28
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-01-07
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2008-06-20
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
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2007-12-04
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2007-12-28
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
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2007-12-06
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2007-12-28
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2018-02-09
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2003-09-15
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2010-02-08
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	1993-01-13
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2008-07-08
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2018-07-27
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2007-05-14
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2007-12-19
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-02-27

Official Correspondent

Michelle Doherty

US Agent Details

Michelle Doherty Business: ICU Medical, Inc. Email: michelle.doherty@icumed.com Phone: (949) 3706562

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

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26
K171373	3M Company	3M Bair Hugger Model 675 Total Temperature Management System	2017-10-10
K083336	Smiths Medical Asd, Inc.	LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL	2009-06-03
K912423	Med Institute, Inc.	VITAL-PORT M.R.I. VASCULAR ACCESS SYSTEM 7012,7112	1991-07-30
K961652	Arrow Intl., Inc.	LOW PROFILE PLASTIC PORT DETACHED CATHETER SYSTEM CATALOG #1017	1996-07-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2010	Cincinnati Sub-Zero Products Inc	2	WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V (sold in the U.S.) and #86185-100 V ( not sold in the U.S.). Intended for warming patients before, during and after surgery, and other specialty procedures.
Z-0021-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
Z-0025-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
Z-0026-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01

Similar Registrations

Registration Number	Establishment Name	Location
3010173425	Synergy Health Westport Ltd	Westport Mayo, IE
8020892	Merck Millipore Ltd.	COUNTY CORK Munster, IE
9611612	PAJUNK GMBH MEDIZINTECHNOLOGIE	GEISINGEN Baden-Wurttemberg, DE
9612003	MILLIPORE S.A.S	MOLSHEIM Grand Est, FR
3010082909	Emsere, Inc.	Peachtree City, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9617604. Last updated year: 2026. Please use registration number 9617604 when referencing this establishment in official correspondence.