FDA.reportPublic FDA data

Bard Access Systems, Inc.

Matched from indexed company URL: Bard Access Systems

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30062607403006260740Bard Access Systems, Inc.1Y2026-01-01605 North 5600 West Salt Lake City UT US 84116

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00801741240034PowerPICC SOLO - Catheter Placement kit+1(800)545-0890medical.services@crbard.com
00801741240041PowerPICC Provena SOLO - Catheter Placement kit+1(800)545-0890medical.services@crbard.com
00801741240058PowerPICC Provena SOLO - Catheter Placement kit+1(800)545-0890medical.services@crbard.com
00801741240065PowerPICC Provena SOLO Catheter with Sherlock 3CG - Catheter Placement kit+1(800)545-0890medical.services@crbard.com
00801741240072PowerPICC Provena SOLO Catheter with Sherlock 3CG - Catheter Placement kit+1(800)545-0890medical.services@crbard.com
10801741075466Securis - SECURIS STABILIZATION DEVICE w/DFU, 1000 units, SECNS01+1(800)545-0890medical.services@crbard.com
10801741163712StatLock Pro - StatLock Pro BNS w/DFU+1(800)545-0890medical.services@crbard.com
10801741163729StatLock Pro - StatLock Pro BNS+1(800)545-0890medical.services@crbard.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
700621548799812P860064DAVOL LONG TERM EPIDURAL CATHETER, CATHETER WITH VITACUFF ANTIMICROBIAL CUFF AND REPAIR KITLNY1988-02-29
700621441992153K993848MILLENNIUM HUBER PLUS SAFETY INFUSION SETFPA2000-01-27
700621066925532K993624SITE-RITE 3 ULTRASOUND SYSTEMIYO1999-11-10
700621274882415K993000BARD HYDROPHILIC COATED GUIDE WIRESDQX1999-11-02
700621453107310K990705MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SETDYB1999-06-28
700621830771178K980994IV ADMINISTRATION SETS WITH NEEDLE ACCESS DEVICESFPA1998-05-29
700621543537808K980992IV ADMINISTRATION SETS WITH NEEDLELESS ACCESS DEVICESFPA1998-05-28
700622045943643K965178NIAGARA DUAL LUMEN CATHETERMPB1997-08-19
700621005362573K964066DUAL SLIM PORT IMPLANTED PORT (0654970/0654940)LJT1997-03-06
700621365885114K955110NAVARRE PERCUTANEOUS BILIARY DRAINAGEFGE1996-11-07
700621373844132K954422PER-Q-CATH MID-LINELJS1995-12-15
700621275020994K954104PER-Q-CATH & PER-Q-CATH DUAL MUMEN CATHETERS, TRAYS & ACCESSORY DEVICESLJS1995-11-21
700621999107005K951907NAVARRE LOCKING PIGTAIL UNIVERSAL DRAINAGE CATHETERGBX1995-05-15
700621578428099K951475NAVARRE UNIVERSAL DRAINAGE CATHETERGBX1995-04-24
700621338910207K946249BARD(R) JEJUNAL FEEDING/GASTRIC DECOMPRESSION TUBESKNT1995-12-11
700621340342360K946249BARD(R) JEJUNAL FEEDING/GASTRIC DECOMPRESSION TUBESKNT1995-12-11
700621145183933K943663NAVARRE 600 ML DRAINAGE BAGEXF1994-09-08
700621621571799K943038STATLOCK-IPIDURALFPA1995-04-10
700621041208174K942931STATLOCK SECUREMENT DEVICESFPA1995-03-28
700621508600562K9263313.0 FR GROSHONG PERIPHER INSERT CENT VENOUS CATHLJS1994-03-07
700621496748274K926139CATHLINK 20 TITANIUM PORT W/ATT. POLYURETHANE CATHLJT1995-01-03
700621286340318K924250PLASTIC LOW PROFILE SUBCUTANEOUS PORTLJT1993-10-04
700621529270858K915841BARD GAUDERER UNIVERSAL PERCUTANEOUS ENDOSCOPICKNT1993-06-25
700621596782597K915837NON-BALLOON REPLACEMENT GASTROSTOMY SYSTEMKNT1993-03-23
700621302568869K915167GESCO PER-Q-CATH CATHETER INTRODUCERDYB1992-01-27
700621308019307K914210VAS-CATH DUALATOR(TM) VESSEL DILATORFKA1993-07-01
700621758308979K914162VAS-CATH FLEXXICON 2 DUAL LUMEN DIALYSIS CATHETERSLFJ1993-07-01
700621953372131K912702PLASTIC ATTACHABLE DUAL PORTLJT1991-09-18
700621433732099K910622GESCO PER-Q-CATH REPAIR KITLJS1991-03-29
700621405464196K904779BUTTON REPLACEMENT GASTROSTOMY DEVICEKGC1991-01-18
700621504644756K904558DUAL LUMEN 5 FR PERIP CENT VEN CATH W/GROSHONG VALFOZ1991-02-11
700621347228780K903530PERCUTANEOUS INTRODUCERSDYB1990-10-22
700621274743694K881743VAS-CATH FLEXXICON DUAL LUMEN DIALYSIS CATHETERLFJ1988-06-23
700621494092634K880571CATH-TECH PORT IMPLANTABLE VASCULAR ACCESS SYSTEMLJT1988-03-04
700621025498031K873213HICKMAN PLASTIC SUBCUTANEOUS PORTLJT1987-10-27
700621188913735K871998GROSHONG CV CATHETER REPAIR KITLJS1987-06-24
700621573255441K871488VAS-CATH PERMANENT DUAL LUMEN HEMODIALYSIS CATHLFJ1987-06-12
700622073605080K871080PERIPHERALLY INSERTED CENTRAL VENOUS CATHETERDQY1987-08-12
700621723960493K870260HICKMAN TITANIUM SUBCUTANEOUS PORTLJT1987-04-15
700621834748142K863606BUTTERFLY NON-CORING NEEDLE SETFMI1986-12-18
700621332671973K862127DYMAX PERSONAL SCANNERIYO1986-12-11
700621043927615K860432PERCUTANEOUS INTRODUCER KITDYB1986-03-31
700621699051130K860256BRAWN AND GROSHONG CATHETERSFOZ1986-03-28
700621962523168K844433VACCESS 2000 SINGLE LUMEN SUBCLAVIAN CANNULALFJ1985-03-13
700621682969405K843083CORMED HUBER POINT NEEDLEGAA1984-09-05
700621389306969K840846STERILE HICHMAN/BROVIAC INJECTION CAPLJS1984-07-06
700621271494613K831386GROSHONG CATHETER, LONG TERM TYPELJS1983-10-14
700621205175991K830406NON-STERILE CATHETER REPAIR KITSLJS1983-03-01
700621401492422K830256NON-STERILE BROVIAC PARENTERAL ALIMI-LJS1983-03-01
700621994827074K830233NON-STERILE,SINGLE/SOUBLE LUMEN-CATHLJS1983-02-28
700621669991411K252478Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable PortLJT2025-09-05
700621530813651K251253PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable PortLJT2025-06-18
700621589503568K242429CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion SystemSEF2025-04-09
700621189516440K242328PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable PortsLJT2024-10-31
700621290846865K241353PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle SetPTI2024-11-27
700621751532459K240359PowerGlide Pro™ Midline CatheterFOZ2024-07-29
700621247749627K240146BD Prevue™ II Peripheral Vascular Access SystemIYO2024-02-18
700621887013443K233106AccuCath Ace™ Intravascular CatheterFOZ2024-04-19
700621810320456K231283SiteRite™ 9 Ultrasound SystemIYO2023-09-11
700621087250660K223198BD Intraosseous Vascular Access System EMS Powered Driver (D001003)MHC2022-11-10
700621140095247K222232Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock AssemblyLJS2022-08-24
700621086868116K213203Provena(TM) Midline CatheterPND2022-05-13
700621658373219K211193BD Prevue II Peripheral Vascular Vascular Access SystemIYO2021-06-25
700621539498141K210264BD PowerPiCC CatheterLJS2021-07-30
700621546270544K203193BD Intraosseous Infusion SystemMHC2021-03-04
700621082372179K201452Groshong NXT PICC CatheterLJS2021-03-12
700621519406148K200266BD Centro Vena Acute Central Line (7 French Dual Lumen)FOZ2020-04-07
700621884653509K191976Piper GO-IO Intraosseous Infusion SystemFMI2019-11-13
700621422357497K191232AccuCath Ace Intravascular CatheterFOZ2019-09-18
700621893470929K191143PowerFlow Implantable Apheresis IV PortPTD2019-08-02
700621707768509K190855BD Acute Central LineFOZ2019-11-01
700621239152177K190527GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis CathetersMSD2020-03-05
700621950604295K182281Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle TechIYO2018-10-24
700621477820725K180560Sherlock 3CG+ T ip Confirmation SystemLJS2018-06-18
700621192890628K1805483F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve TechnologyLJS2018-04-26
700622056159273K172397Sherlock 3CG Tip Positioning System StyletLJS2017-09-29
700621017765497K171735PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle SetPTI2017-08-08
700621155861243K171348Pinpoint GT Needle Guide KitsITX2017-05-22
700622036414969K170158PowerGlide ST Midline CatheterPND2017-06-01
700622064834153K163458Zenysis Short-Term Dialysis CatheterMPB2017-04-04
700621208530696K163437hypodermic Pinpoint™ GT NeedlePVZ2017-06-23
700621288726400K163216Pinpoint GT NeedlesBSP2017-06-27
700622016335995K163001PowerFlow Apheresis I.V. PortPTD2017-04-17
700621851483549K162900PowerMidline CatheterPND2016-12-14
700621257442453K162894AccuCath Intravascular CatheterFOZ2016-11-15
700621490459762K162769Pinpoint GT Introducer NeedleDYB2016-11-04
700621523748305K162443PowerPICC Provena CathetersLJS2016-10-25
700622051219401K162441PowerPICC Provena Catheters with SOLO Valve TechnologyLJS2017-04-24
700621224489251K162377PowerGlide Pro Midline CatheterFOZ2016-09-22
700621499178415K153440PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle SetFPA2016-08-18
700621250810394K153393PowerMidline CatheterPND2016-06-28
700621166809532K153298AccuCath Intravascular CatheterFOZ2015-12-10
700621035312373K153280PowerGlide Pro Midline CatheterFOZ2016-06-02
700621964434741K153190Zenysis Short-Term Dialysis CatheterMPB2016-01-05
700621537356588K152554Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT TechnologyIYO2015-12-14
700621512076487K151985PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH CatheterLJS2016-06-14
700621706872265K150529Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound SystemIYO2015-03-30
700621862423587K150514Power-Injectable Implantable Ports with ChronoFlex Polyurethane CathetersLJT2015-11-20
700621249985621K142445PINPOINT GT SAFETY INTRODUCER NEEDLEDYB2015-04-13
700621366496814K142267Sherlock 3CG Tip Positioning System StyletLJS2014-10-17
700622013239823K142136ACCUCATH MIDLINE CATHETER SYSTEMFOZ2015-01-08
700621589734316K141634NAUTILUS DELTALJS2015-01-27
700621877329914K141531POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETERNIE2015-06-01
700621340776444K140504ACCUCATH BC INTRAVASCULAR CATHETER SYSTEMFOZ2014-07-17
700621177467113K140345THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS)LJS2014-03-14
700621127403173K133856POWERGLIDE MIDLINE CATHETERFOZ2014-01-16
700621168305174K133456POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETERNIE2014-09-24
700621242515245K132942SITE-RITE VISION II ULTRASOUND SYSTEMIYN2013-10-17
700621943124482K122899POWERPORT CLEARVUE SLIM IMPLANTABLE PORTLJT2012-11-15
700621767740942K121485GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSINGQSY2012-08-21
700621516664828K121073POWERGLIDE MIDLINE CATHETERFOZ2012-06-01
700622005993443K120882SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDEIYO2012-05-30
700621001711949K113808THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS)LJS2012-03-19
700621853828832K112791SITESCRUB IPA DEVICELKB2012-02-24
700621137372432K112744SAPIENS TIP CONFIRMATION SYSTEMLJS2011-10-20
700621129120029K112347RAPID INTRAVASCULAR CATHETER START SYSTEM 22 GAUGE / 20 GAUGE / 18 GAUGEFOZ2011-09-22
700621630221286K103109PONSKY* NON-BALLOON REPLACEMENT GASTROSTOMY TUBEKNT2010-12-22
700621945530756K102405INFUSION SET FOR POWERPICC SOLO 2 CATHETERFPA2011-07-21
700621663954166K102159POWERPICC SV CATHETERSLJS2010-11-17

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LJS502022-08-24
MSD272020-03-05
LJT232025-09-05
FOZ182024-07-29
FPA142016-08-18
IYO112024-02-18
DYB102016-11-04
KNT72010-12-22
MPB62017-04-04
NFK52010-07-29
LFJ51993-07-01
PND42022-05-13
ITX32017-05-22
PTI22024-11-27
MHC22022-11-10
FMI22019-11-13
PTD22019-08-02
NIE22015-06-01
IYN22013-10-17
QSY22012-08-21
FKA22002-10-11
GBX21995-05-15
SEF12025-04-09
BSP12017-06-27
PVZ12017-06-23
LKB12012-02-24
LDF12003-11-20
DQX11999-11-02
FGE11996-11-07
EXF11994-09-08
KGC11991-01-18
LNY11988-02-29
DQY11987-08-12
GAA11984-09-05

PMN#

GUDID#

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