Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012542015

FEI Number

3012542015

Entity Name

ICU Medical Nederland B.V.

City/State/Country

Wijchen Gelderland, NL

Establishment Address

Bijsterhuizen 22 - 08, Wijchen Gelderland 6604 LD, NL

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on 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

N/A

PMA Number

N/A

All Registered Proprietary Names

Sodasorb Portex Blue Line Ultra Tracheostomy Kit Suctionaid Portex Blue Line Ultra Suctionaid Trachostomy Tube Kits BL Ultra Suctionaid Change Kits Blue Line Ultra Suctionaid Portex Mini-Trach II Portex Epidural Filter Portex BLUselect Tracheostomy Tube Portex BLUselect Suctionaid Tracheostomy Tube Portex BLUselect Tracheostomy Inner Cannula 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 BLUperc Percutaneous Dilation Tracheostomy Procedural Kit or Tray with or without BLUselect Tracheostomy Tube BLUgriggs Percutaneous Dilation Tracheostomy Procedural Kit or Tray with BLUselect Tracheostomy Tube with or without Europa Lunar Callisto Optima Macintosh Miller HemoDraw EzPAP PORTEX CUFF PRESSURE GAUGE Pneupac paraPAC plus Disposable CPAP Circuit Pneupac paraPAC plus PROTECTIV Jelco Jelco-W I.V. Catheter Cathlon Optiva Jelco ProtectIV-W Safety IV Catheter Jelco ProtectIV Plus-W Safety IV Catheter Portex Emergency Cricothyroidotomy Portex Emergency Cricothyroidotomy Kit Portex UniPerc Adjustable Flange Tracheostomy Tube UniPerc PDT Kit UniPerc Percutaneous Dilation Tracheostomy Kit Tracheal tube holders Portex Portex Tube Securement Other (IFE)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CBL	Absorbent, Carbon-Dioxide	Anesthesiology	Class 1	868.5300	2009-05-21
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
BSN	Filter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5130	2009-03-19
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	2007-12-04
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2018-11-09
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2018-11-09
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2003-09-15
CBT	Arterial Blood Sampling Kit	Anesthesiology	Class 1	868.1100	2007-11-28
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	Class 2	868.5690	2007-12-20
JYJ	Gauge, Measuring	Ear, Nose, Throat	Class 1	874.4420	1998-01-07
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
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2007-11-28
BWC	Needle, Emergency Airway	Anesthesiology	Class 2	868.5090	2010-04-07
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2009-08-31
JAY	Support, Breathing Tube	Anesthesiology	Class 1	868.5280	2003-09-15

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
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
K862192	U.O. Equipment Co.	RESUSCITATOR MODELS 10400/10500/10600/10700/10800	1986-07-07
K943349	Quinton, Inc.	MAHURKAR DUAL LUMEN CATHETER	1995-03-22

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.
Z-0144-2024	Covidien	1	Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only
Z-0004-2025	Mercury Enterprises, Inc. dba Mercury Medical	2	Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.

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3017434950	JIANSHI Biotechnology (Zhejiang) Co., Ltd.	Yuyao Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012542015. Last updated year: 2026. Please use registration number 3012542015 when referencing this establishment in official correspondence.