FDA.reportPublic FDA data

ICU Medical Nederland B.V.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30125420153012542015ICU Medical Nederland B.V.1N2026-01-01Bijsterhuizen 22 - 08 Wijchen Gelderland NL 6604 LD

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1944191196458008K991300BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICEBWF1999-07-12
1944191920063715K990236MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECTFOZ1999-08-20
1944191532066572K961404MX960 REUSABLE PRESSURE TRANSDUCERDRS1996-06-27
1944191607326188K862167MINI-TRACH KITBTO1986-08-06
1944191541024899K173912BLUperc 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 tubeJOH2018-05-08
1944191776029749K173384BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tubeBTO2018-04-10
1944191055034103K123957PNEUPAC PARAPAC PLUSBTL2013-09-16
1944191796208752K083451PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYSBSN2009-03-04
1944191195730392K083031PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KITBTO2009-08-18
1944191287708671K071269HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEMCBT2007-08-01
1944191662036721K050166PORTEX EMERGENCY CRICOTHYROIDOTOMY KITBWC2005-05-26
1944191836204130K041348PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRAJOH2004-07-13
1944191962105028K040014PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLYJOH2004-02-13
1944191577394444K030570BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBEBTO2003-09-17
1944191779782418K030381PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULABTO2003-08-27
1944191391044400BK020043
1944191036622375
1944191141234884
1944191483961344
1944191766334843

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
BTO52018-04-10
JOH32018-05-08
BTL12013-09-16
BSN12009-03-04
CBT12007-08-01
BWC12005-05-26
FOZ11999-08-20
BWF11999-07-12
DRS11996-06-27