Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011237704

FEI Number

3011237704

Entity Name

ICU Medical Czech Republic a. s.

City/State/Country

Hranice Olomoucky Kraj, CZ

Establishment Address

Olomoucka 306, Hranice Olomoucky Kraj 753 01, CZ

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

K965017

PMA Number

N/A

All Registered Proprietary Names

LogiCal(R) Portex BLUselect Tracheostomy Tube Portex BLUselect Suctionaid Tracheostomy Tube Portex BLUselect Tracheostomy Inner Cannula Portex UniPerc Adjustable Flange Tracheostomy Tube UniPerc PDT Kit UniPerc Percutaneous Dilation Tracheostomy Kit Portex Blue Line Ultra Tracheostomy Kit Suctionaid Portex Blue Line Ultra Suctionaid Trachostomy Tube Kits BL Ultra Suctionaid Change Kits Blue Line Ultra Suctionaid 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 Pneupac paraPAC plus Disposable CPAP Circuit Pneupac paraPAC plus HemoDraw 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 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2007-11-28
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2018-11-09
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2009-08-31
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2007-12-04
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2007-12-04
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2013-09-24
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2013-09-24
CBT	Arterial Blood Sampling Kit	Anesthesiology	Class 1	868.1100	2007-11-28
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
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	1993-01-13

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
1824231	ICU Medical, Inc.	Gary, IN, US
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
K862192	U.O. Equipment Co.	RESUSCITATOR MODELS 10400/10500/10600/10700/10800	1986-07-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2025	Mercury Enterprises, Inc. dba Mercury Medical	2	Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.

Similar Registrations

Registration Number	Establishment Name	Location
1423395	MEDLINE INDUSTRIES, LP - SPT	Waukegan, IL, US
3009156722	SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.	Shenzhen Guangdong, CN
1422634	MEDLINE INDUSTRIES, LP (Northpoint Services)	Waukegan, IL, US
1713468	ICU MEDICAL, INC	Salt Lake City, UT, US
1721676	Sterigenics U.S., LLC	Salt Lake City, UT, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011237704. Last updated year: 2026. Please use registration number 3011237704 when referencing this establishment in official correspondence.