Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1526863

FEI Number

1526863

Entity Name

ICU Medical, Inc.

City/State/Country

DUBLIN, OH, US

Establishment Address

6250 Shier Rings Rd, DUBLIN, OH 43016, US

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

K101422

PMA Number

N/A

All Registered Proprietary Names

Medflator II DHD Cliniflo® Low Flow Exerciser DHD CliniFlo EASIVENT NIF-TEE NIF KIT RESCAL Portex 1st Response Adult Manual Resuscita PEEP Valve Exhalation filter DHD LONG TERM ENDOT BIVONA SECUREEASY Thera-Mist NovaTrans(R) Medex Tubing Connectors & Stopcocks EXERCISER INSPIRATORY MUSCLE TRAINER KIT injection adapter Stealth Medex Various IV administration sets KidsKit (R) Secure (R) various clamps and brackets RESERVOIR BAG Flo2 Anesthesia Breathing Bag FACEPLATE NIF-TEE PALM CUP PERCUSSOR Portex Flo-Mist TranStar (R) TranStar Portex Blue Line Ultra Tracheostomy Kit Suctionaid Portex Blue Line Ultra Suctionaid Trachostomy Tube Kits BL Ultra Suctionaid Change Kits Blue Line Ultra Suctionaid ACE Low pressure ext. tubing High pressure ext. tubing AsthmaKit Medex Bacterial Filter Thera-Mist VACON OXYPEEP FLO2 First breath 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 ACE MEDEX STOPCOCK & LUER LOCK PLUG

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2020-06-24
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2020-06-24
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2020-06-24
MAV	Syringe, Balloon Inflation	Cardiovascular	Class 2	870.1650	2007-11-28
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
BXR	Meter, Airway Pressure (Inspiratory Force)	Anesthesiology	Class 2	868.1780	2007-08-13
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2007-12-04
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2003-09-15
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2007-12-20
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2007-11-28
NEP	System/Device, Pharmacy Compounding	General Hospital	Class 2	880.5440	2020-05-06
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2007-08-13
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-11-28
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2012-03-08
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	Class 2	868.5690	2020-01-09
FPB	Filter, Infusion Line	General Hospital	Class 2	880.5440	2007-11-28
CBT	Arterial Blood Sampling Kit	Anesthesiology	Class 1	868.1100	2007-11-28
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2008-06-02
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2003-09-15
OFD	Catheter Introducer Kit	Cardiovascular	Class 2	870.1340	2020-06-24
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2007-08-13
FEN	Device, Cystometric, Hydraulic	Gastroenterology, Urology	Class 2	876.1620	2010-07-27
BYI	Percussor, Powered-Electric	Anesthesiology	Class 2	868.5665	2007-08-13
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2007-12-20
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2007-11-28
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2020-06-24
DPT	Probe, Blood-Flow, Extravascular	Cardiovascular	Class 2	870.2120	2008-03-03
OXQ	Dressing Change Tray	General Hospital	Class 1	880.5075	2020-06-24
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2007-12-04
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2007-08-13
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2010-07-27
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2007-12-20
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2007-11-28
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2007-12-20
CBD	Bottle, Collection, Breathing System (Calibrated)	General Hospital	Class 2	880.6740	2007-01-04
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2003-09-15
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	1992-10-02
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2020-07-08
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2007-12-20
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2020-02-27
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2020-07-08

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
3012307300	ICU Medical, Inc.	Minneapolis, MN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K101883	St Jude Medical	6F ENGAGE/ENGAGE TR INTRODUCER	2010-09-07
K034025	Nmt Medical, Inc.	NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC	2004-03-26
K122854	Arrow International (Subsidiary of Teleflex Inc.)	ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER	2013-01-04
K233691	Acutus Medical, Inc.	FlexCath Cross Transseptal Solution	2023-12-17
K915078	North American Instrument Corp.	MORSE HEMOSTATIC CATHETER INTRODUCER SET	1992-06-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0783-2020	Abbott Medical	2	Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020	Abbott Medical	2	Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
Z-0001-2010	Penumbra Inc.	2	Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014	Cordis Corporation	2	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1526863. Last updated year: 2026. Please use registration number 1526863 when referencing this establishment in official correspondence.