Data / Medical devices / Netherlands / ICU Medical Nederland B.V.
ICU Medical Nederland B.V.: FDA-registered device maker in Wijchen Gelderland, Netherlands, 15 510(k) clearances
ICU Medical Nederland B.V. is registered with the FDA (registration 3012542015) in Wijchen Gelderland, Netherlands. It lists 15 device types. The FDA files 15 510(k) clearances under its listings, the newest dated May 8, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012542015
- Address
- Bijsterhuizen 22 - 08, Wijchen Gelderland, Netherlands, 6604 LD
- Owner or operator
- ICU Medical, Inc. (8020727)
- Roles
- Exporter to the US
- First device listed
- January 7, 1998
- Registered through
- 2026
- Brand names listed
- BL Ultra Suctionaid Change Kits, BLUgriggs Percutaneous Dilation Tracheostomy Procedural Kit or Tray with BLUselect Tracheostomy Tube with or without, BLUperc Percutaneous Dilation Tracheostomy Procedural Kit or Tray with or without BLUselect Tracheostomy Tube, Blue Line Ultra Inner Cannulas, Blue Line Ultra Suctionaid, Blue Line Ultra Tracheostomy Tubes and Kits, Callisto, Cathlon and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 8, 2018 | K173912 | BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube | JOH | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| April 10, 2018 | K173384 | BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube | BTO | Substantially Equivalent | Smiths Medical Ads, Inc. | accessdata.fda.gov |
| September 16, 2013 | K123957 | PNEUPAC PARAPAC PLUS | BTL | Substantially Equivalent | Smiths Medical International , Ltd. | accessdata.fda.gov |
| August 18, 2009 | K083031 | PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT | BTO | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| March 4, 2009 | K083451 | PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS | BSN | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| August 1, 2007 | K071269 | HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM | CBT | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| May 26, 2005 | K050166 | PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT | BWC | Substantially Equivalent | Smiths Medical | accessdata.fda.gov |
| July 13, 2004 | K041348 | PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA | JOH | Substantially Equivalent | Smiths Medical | accessdata.fda.gov |
| February 13, 2004 | K040014 | PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLY | JOH | Substantially Equivalent | Portex , Ltd. | accessdata.fda.gov |
| September 17, 2003 | K030570 | BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE | BTO | Substantially Equivalent | Portex , Ltd. | accessdata.fda.gov |
| August 27, 2003 | K030381 | PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA | BTO | Substantially Equivalent | Portex , Ltd. | accessdata.fda.gov |
| August 20, 1999 | K990236 | MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT | FOZ | Substantially Equivalent | Johnson & Johnson Medical, Div. of Ethicon, Inc. | accessdata.fda.gov |
| July 12, 1999 | K991300 | BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICE | BWF | Substantially Equivalent | Dhd Healthcare Corp. | accessdata.fda.gov |
| June 27, 1996 | K961404 | MX960 REUSABLE PRESSURE TRANSDUCER | DRS | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
| August 6, 1986 | K862167 | MINI-TRACH KIT | BTO | Substantially Equivalent | Portex, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Emergency Airway
- All makers of Tube, Tracheostomy (W/Wo Connector)
- All makers of Gauge, Measuring
- All makers of Ventilator, Emergency, Powered (Resuscitator)
- All makers of Attachment, Breathing, Positive End Expiratory Pressure
- All makers of Warmer, Blood, Non-Electromagnetic Radiation
Updated May 8, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.