Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027579175

FEI Number

3027579175

Entity Name

ICU Medical, Inc.

City/State/Country

Highland, IN, US

Establishment Address

2625 Main St, Highland, IN 46322, 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

K810436

PMA Number

N/A

All Registered Proprietary Names

Bivona® Mid-Range Aire-Cuf® Adult Tracheostomy Tubes Bivona® Uncuffed Neonatal and Pediatric Tracheostomy Tubes Bivona® Aire-Cuf® Neonatal and Pediatric Tracheostomy Tubes MULTIPLE BIVONA MULTIPLE BIVONA (IFE) Bivona® Aire-Cuf® Tracheostomy Tubes Bivona® Cuff Maintenance Device (CMD¿)open Bivona Disconnect Wedge Bivona® Fome-Cuf® Tracheostomy Tubes Bivona® Fome-Cuf® Adult Tracheostomy Tubes with Talk Attachment Bivona® Uncuffed Neonatal and Pediatric FlexTend Plus Silicone Tracheostomy Tubes Bivona MULTIPLE BIVONA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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	2008-06-20
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	2007-11-30
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
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
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2008-06-20
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	2009-12-17
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2007-11-30

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
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-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.

Similar Registrations

Registration Number	Establishment Name	Location
2936999	Covidien	Lafayette, CO, US
3030733800	AD SUPPLY GROUP LIMITED	London London, City of, GB
1824231	ICU Medical, Inc.	Gary, IN, US
3014054118	FOGLESS INTERNATIONAL AB	Vaggeryd Jonkoping, SE
3030626857	PALM MEDICAL INTERNATIONAL BV	Buggenhout Oost-Vlaanderen, BE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027579175. Last updated year: 2026. Please use registration number 3027579175 when referencing this establishment in official correspondence.