ICU Medical, Inc.

FDA Device Registration & Listing · Gary, IN, US · Registration 1824231

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1824231
FEI Number
1824231
Entity Name
ICU Medical, Inc.
City/State/Country
Gary, IN, US
Establishment Address
5700 W 23rd Ave, Gary, IN 46406, 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
N
Expiration Date (Year)
2026
510(k) Number
K792035
PMA Number
N/A

All Registered Proprietary Names

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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CBH Device, Fixation, Tracheal Tube Anesthesiology Class 1 868.5770 2003-09-15
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
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 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 2008-11-18
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 2008-06-20
BTO Tube, Tracheostomy (W/Wo Connector) Anesthesiology Class 2 868.5800 2008-06-20
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 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
1526863 ICU Medical, Inc. DUBLIN, OH, US
3012307300 ICU Medical, Inc. Minneapolis, MN, 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
K233341 Covidien, LLC Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410) 2024-05-20
K243785 Covidien, LLC Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless Reinforced 2025-09-25

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1824231. Last updated year: 2026. Please use registration number 1824231 when referencing this establishment in official correspondence.
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