Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1219611

FEI Number

1219611

Entity Name

ICU Medical, Inc.

City/State/Country

SOUTHINGTON, CT, US

Establishment Address

201 W Queen St, SOUTHINGTON, CT 06489, 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

K913859

PMA Number

N/A

All Registered Proprietary Names

ViaValve Jelco ViaValve Safety IV Catheter Bivona® Fome-Cuf® Tracheostomy Tubes Bivona Disconnect Wedge Pulsator Pro-Vent Line Draw Filter-Pro MULTIPLE BIVONA MULTIPLE BIVONA (IFE) Needle-Pro Edge Acuvance Acuvance Jelco Safety IV Catheter Bivona ViaValve Wing Jelco ViaValve-W Safety IV Catheter Jelco ViaValve Safety IV Catheter Bivona® Cuff Maintenance Device (CMD¿)open Bivona® Mid-Range Aire-Cuf® Adult Tracheostomy Tubes

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2012-08-10
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	2008-06-20
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2007-12-19
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
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2007-12-21
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2007-11-30
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2009-12-17
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2016-08-20
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	2008-06-20

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

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K943349	Quinton, Inc.	MAHURKAR DUAL LUMEN CATHETER	1995-03-22
K912158	Medical Device Inspection Co., Inc.	CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY	1991-10-23
K142298	Covidien	Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff	2015-02-13
K182861	Covidien	Shiley Neonatal/Pediatric Tracheostomy Tube	2019-03-22
K142296	Covidien	Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula	2015-02-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0003-2024	ARROW INTERNATIONAL Inc.	2	Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0009-2023	B Braun Medical Inc	2	Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
Z-0025-2024	Becton Dickinson Infusion Therapy Systems Inc.	2	REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO
Z-0044-2017	Teleflex Medical	2	Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen tracheas. When using cannulas with curr. For short term intermittent inflation.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1219611. Last updated year: 2026. Please use registration number 1219611 when referencing this establishment in official correspondence.