ICU Medical Nederland B.V.

Registration Details

Registration Name: ICU Medical Nederland B.V.
Registration Number: 3012542015
FEI Number: 3012542015
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: Bijsterhuizen 22 - 08
City: Wijchen Gelderland
Country: NL

Regulatory Submissions

510(k) Number: K030570

Owner / Operator

Firm Name: ICU Medical, Inc.
Operator Number: 8020727
Address: 951 Calle Amanecer
City: San Clemente
State: CA
Postal Code: 92673
Country: US
Correspondent: Michelle Doherty

US Agent

Business Name: ICU Medical, Inc.
Contact Name: Michelle Doherty
Address: 951 Calle Amanecer
City: San Clemente
State: CA
ZIP: 92673
Country: US
Email: [email protected]
Phone: 949 3706562

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Absorbent, Carbon-Dioxide	CBL	Class 1	Anesthesiology	No	2009-05-21
Tube, Tracheostomy (W/Wo Connector)	BTO	Class 2	Anesthesiology	No	2007-12-04
Filter, Conduction, Anesthetic	BSN	Class 2	Anesthesiology	No	2009-03-19
Tube Tracheostomy And Tube Cuff	JOH	Class 2	Anesthesiology	No	2018-11-09
Laryngoscope, Rigid	CCW	Class 1	Anesthesiology	No	2003-09-15
Arterial Blood Sampling Kit	CBT	Class 1	Anesthesiology	No	2007-11-28
Spirometer, Therapeutic (Incentive)	BWF	Class 2	Anesthesiology	No	2007-12-20
Gauge, Measuring	JYJ	Class 1	Ear, Nose, Throat	No	1998-01-07
Ventilator, Emergency, Powered (Resuscitator)	BTL	Class 2	Anesthesiology	No	2013-09-24
Attachment, Breathing, Positive End Expiratory Pressure	BYE	Class 2	Anesthesiology	No	2013-09-24
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	FOZ	Class 2	General Hospital	No	2007-11-28
Needle, Emergency Airway	BWC	Class 2	Anesthesiology	No	2010-04-07
Support, Breathing Tube	JAY	Class 1	Anesthesiology	No	2003-09-15
Warmer, Blood, Non-Electromagnetic Radiation	BSB	Class 2	Hematology	No	2007-12-28
Transducer, Blood-Pressure, Extravascular	DRS	Class 2	Cardiovascular	No	2007-11-28

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 Tube Securement Other (IFE) Portex PDT Trachesotomy kit Portex Percutaneous Dilation Trachesotomy kit Portex Percutaneous Dilation Tracheostomy Kit Portex Blue Line Ultra® tracheostomy tubes Portex ULTRAperc tracheostomy apparatus and instruments PORTEX ULTRAPERC Level 1® H-1200 Fast Flow Fluid Warmer LogiCal(R)

Establishment Types

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