FDA.report

Cardinal Health 200, LLC

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
14235373001236905Cardinal Health 200, LLC1Y2026-01-013651 Birchwood Drive Waukegan IL US 60085
16234861623486CARDINAL HEALTH 200, LLC1N2026-01-01200 MCKNIGHT ST. Jacksonville TX US 75766
30073290203007329020Cardinal Health 200, LLC1N2026-01-011320 Don Haskins Suite A El Paso TX US 79936
10658313002973487CARDINAL HEALTH 200, LLC1N2020-04-25785 FORT MILL HWY. FORT MILL SC US 29707
16232231623223CARDINAL HEALTH 200, LLC1Y2020-04-251 Butterfield Trail Blvd EL PASO TX US 79906
19403731940373CARDINAL HEALTH 200, LLC1N2020-04-25808 W Highway 24 MOBERLY MO US 65270

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
167311786243629P190007Cardinal Health Multifunctional Defibrillation ElectrodeMKJ 2020-08-07
167311124380504K993463INTRAVASCULAR ADMINISTRATION SETFPA2000-01-04
167201488739097K993063RUSCH BRILLANT SILICONE FOLEYEZL1999-12-09
167311488739097K993063RUSCH BRILLANT SILICONE FOLEYEZL1999-12-09
167201419056458K992436GOWN BACK, MODEL 13-403N; 13-404N; 13-405NFYA2000-01-20
167311419056458K992436GOWN BACK, MODEL 13-403N; 13-404N; 13-405NFYA2000-01-20
167311708080471K992171COATED STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)KGO1999-09-14
167201708080471K992171COATED STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)KGO1999-09-14
167311624338852K991758MONOJECT INSULIN SYRINGEFMF1999-06-14
167311361531283K990530KERLIX MD ANTIMICROBIAL GAUZE DRESSINGNAD2000-01-31
167311167856607K990500KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946CEZL1999-09-28
167201312298735K990236MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECTFOZ1999-08-20
167201787004860K984084BARDEX LUBRI-SIL FOLEY CATHETEREZL1999-02-01
167311173586416K983952GREINER VACUETTE BLOOD COLLECTION TUBEJKA1998-12-28
167311105770366K983187MEDSOL GOLDENBERG BONE MARROW BIOPSY NEEDLEKNW1998-12-10
167311079926431K983097TENS/FES/NMES ELECTRODESGXY1999-09-17
167311128759395K982652ALLEGIANCE PORTA-WARM MATTRESSIMD1999-01-21
167321128759395K982652ALLEGIANCE PORTA-WARM MATTRESSIMD1999-01-21
167311178803548K982269CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GAMIA1998-07-23
167201303122369K981956DEGANIA SILICONE IDENTI LOOPSDXC1998-07-09
167311303122369K981956DEGANIA SILICONE IDENTI LOOPSDXC1998-07-09
167201273306565K980987BECTON DICKINSON SYRINGEFMF1998-06-11
167311380092343K980857MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODEMKJ1998-05-12
167311048539383K980490SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPSMMK1998-02-24
167201126950132K980210VARIOUS SURGICAL OR PATIENT DRAPESKKX1998-05-15
167311149482959K9739112 GALLON ALTERNATE CARE SHARPS CONTAINERFMI1997-10-29
167312008243961K973763KENDALL CURITY IODOFORM PACKING STRIPEFQ1997-12-31
167311389919682K973619KENDALL CURITY NON-ADHERING DRESSINGKMF1997-12-10
167311922813762K973546KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETEREZD1997-11-07
167311130224761K973511KENDALL CURITY PETROLATUM GAUZEFRO1997-12-16
953261808379718K973507KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)FRO1997-12-15
167311808379718K973507KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)FRO1997-12-15
167311404415970K973409KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPSKNT1998-02-27
167311001287964K972901AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORDGEI1997-09-19
167201001287964K972901AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORDGEI1997-09-19
167311863910526K972615CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)LYY1999-01-26
167311992835261K971849CYTOLOGY BRUSHHHT1997-07-24
167201870701616K971540AMERICAN BIOSURGICAL ELECTROSURGICAL MONOPOLAR CABLE/CORDGEI1997-08-14
167311984010685K971472SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPAQUE SHEETING, REINFORCED RADIOPAQUE SHEETING, EXTRA FIRM GRAFTL1997-07-01
167311155289470K971449VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE)GIM1997-06-17
167201155289470K971449VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE)GIM1997-06-17
167201943067778K971339INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERSFOZ1997-12-24
167311943067778K971339INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERSFOZ1997-12-24
167201471648673K971159SURGICAL DRAPESKKX1997-06-24
167311722998498K970855CLAVE CONNECTORFPA1997-06-24
167202050628551K970554CONVERTORS SMS DRAPESKKX1997-05-27
167201450476331K964435PRIMARY IV SETFMG1997-04-02
167311450476331K964435PRIMARY IV SETFMG1997-04-02
167311789458758K964425A-V IMPULSE SYSTEM MODEL 6060JOW1997-07-28
167312064461347K964387POINT OF USE II SHARPS-A-GATORMMK1997-03-27
167311334968856K964279SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)KXO1997-01-22
167201067409825K964142MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNSKKX1997-02-25
167312071643354K963351LIFESHIELD BLUNT CANNULAFMI1997-02-26
167311737949878K962332TENS/FES/NMES ELECTRODESGZJ1996-07-31
167312063513226K961993BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT)MLS1996-07-03
167311335882377K961341CONVERTORS POLYOLEFIN FABRIC GOWNSFYA1996-10-28
167311782414199K961154BAXTER SODIUM ACETATE INFANT HEEL WARMERMPO1996-06-06
167321782414199K961154BAXTER SODIUM ACETATE INFANT HEEL WARMERMPO1996-06-06
167311752693403K960982MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULAFMI1996-12-23
167311279582537K960677KANGAROO JEJUNAL FEEDING SYSTEMKNT1996-05-13
167311424226738K960632KANGAROO FEEDING TUBE PLACMENT STYLETKNT1996-05-09
167311734939279K955882MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR HEWLETT PACKARD DEFIBRILLATORSMKJ1996-10-24
167311538100439K955785TS PERCUTANEOUS ARTERIAL/VENUS CATHETER INTRO SETDYB1996-03-12
167201538100439K955785TS PERCUTANEOUS ARTERIAL/VENUS CATHETER INTRO SETDYB1996-03-12
167311744219563K955557FLUID REISISTANT EYESHIELD MASKFXX1996-04-25
167311651252754K955556FLUID RESISTANT MASKFXX1996-04-25
167261651252754K955556FLUID RESISTANT MASKFXX1996-04-25
167311373308482K954853AUTO SUTURE SUTURE CLOSUREGCJ1995-12-20
167201373308482K954853AUTO SUTURE SUTURE CLOSUREGCJ1995-12-20
167311410904504K954429KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KITKNT1996-03-08
167201050007029K953889AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORDGEI1995-10-18
167311050007029K953889AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORDGEI1995-10-18
167311479934668K952945AQUAFLO HYDROGEL WOUND DRESSING & PACKERNAE1995-08-23
167311361905846K952861ANGIOCATH & INSYTE AUTOGUARD CATHETERSFOZ1995-07-31
167201361905846K952861ANGIOCATH & INSYTE AUTOGUARD CATHETERSFOZ1995-07-31
167201511062643K952414PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETERKNY1995-06-23
167311126922988K952204CONMED/ASPEN LABS COATED LAPAROSCOPIC ELECTROSURGICAL BLADESGEI1995-05-25
167311692515996K951738ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETERFOS1995-09-29
167311520111184K951737ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER INSERTION TRAYFOS1995-09-28
167311646997431K951722PERCEPTOR COMPENSATOR MORSE MANIFOLDDRS1996-03-25
167201646997431K951722PERCEPTOR COMPENSATOR MORSE MANIFOLDDRS1996-03-25
167311141994175K951488KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAPKNY1995-04-25
167311395102172K950775CURASORB ZN ALGINATE WOUND DRESSINGKMF1995-04-03
167312015922618K950680INFANT HEEL WARMERIMD1995-08-23
167322015922618K950680INFANT HEEL WARMERIMD1995-08-23
167201884145993K950301ANGIOCATH(R) NONVALON(R) AND ANGIO-SET(R) IV CATHETERSFOZ1995-04-18
167311884145993K950301ANGIOCATH(R) NONVALON(R) AND ANGIO-SET(R) IV CATHETERSFOZ1995-04-18
167311450390026K946173STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILKGAQ1995-01-09
167311448308029K945964KANGAROO(R) 524 ENTERAL FEEDING PUMP AND ADMINISTRATION SETSLZH1995-03-07
167311109136821K945952VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBEJKA1995-01-18
167312033670327K945715MONOJECT(R) PISTON SYRINGES; 3,6,12,20,35 AND 60CC SIZESFMF1995-03-01
167311447629998K945197THE SHARPS COLLECTION AND DISPOSAL SYSTEMMMK1994-12-02
167311394569970K943897NU-SITEFPA1995-02-10
167311090429166K943660PHLEBOTOMY SHARPS DISPOSAL CONTAINERSMMK1995-03-22
167311761496785K943659ANCILLARY AND LARGE VOLUME SHARPS DISPOSAL CONTAINERSMMK1995-03-22
167311110216040K943658CHEMOTHERAPY WASTE DISPOSAL CONTAINERSMMK1995-03-22
167311386553081K943636CURADERM ALGINATE HYDROCOLLOIDKMF1994-10-03
167311021679419K943485MONOJECT HORIZONTAL ENTRY SHARPS CONTAINERFMI1994-09-09
167311055013909K943073CURAFIL WOUND GEL DRESSINGMGQ1994-07-26
167311397274496K942564ARGYLE NEO-SERTFOS1994-08-25
167311300126997K942394SAFE VENT SYSTEMFMF1995-01-27
167311006887919K941991IN-ROOM AND SHARPSTARMMK1994-08-29
167311134769465K941814ARGYLE DUAL LUMEN UMBILICAL VESSEL CATHETERFOS1994-09-30
167311383954608K935238ARGYLE TURKEL SAFETY PARACENTESIS PROCEDURE TRAYFRG1994-02-17
167311053651040K935086AUTO SUTURE DISPOSABLE OPTICAL TROCARGCJ1994-02-17
167201053651040K935086AUTO SUTURE DISPOSABLE OPTICAL TROCARGCJ1994-02-17
167311447254740K934428ARGYLE TURKEL SAFETY PNEUMOTHORAX PROCEDURE TRAYLRO1993-12-30
167311890008650K933700DYE MANAGEMENT SYSTEMDQO1993-11-03
167201890008650K933700DYE MANAGEMENT SYSTEMDQO1993-11-03
167311510856336K933689MODIFICATION OF KENDALL CURASORB CALCIUM ALGINATE WOUND DRESSINGKMF1993-12-13
167311739989981K933520ENDOSCOPIC ANTI-FOG KIT, 100-302-00GCJ1993-08-24
167311393520071K933400KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMPERATURE SENSORKOD1993-11-15
167311547585143K932513LABELING FOR MYO/WIRE II STERNOTOMY SUTURESGAO1994-01-07
167201680015005K932512MULTI-PORT MANIFOLDFMG1994-02-22
167311680015005K932512MULTI-PORT MANIFOLDFMG1994-02-22
167311426742463K932295NON-BALLOON REPLACEMENT GASTROSTOMY KITKNT1994-09-08
167311335499454K930955CERVEX-BRUSHHHT1994-05-24
167201963839155K926217TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USEGBZ1993-07-13
167311963839155K926217TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USEGBZ1993-07-13
167311157281746K925790EXAC-TEMP & CLINI-TEMP FOLEY CATHETER'SEYC1993-05-17

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
KNT252018-10-23
FYA202023-07-27
KGO202021-09-26
KOD152004-07-20
FMF142025-08-22
GEI142003-03-07
JOW122023-04-03
EZL122007-12-07
GIM121997-06-17
FOZ111999-08-20
FXX102023-07-03
KKX102005-04-25
GXY92009-04-21
FRG82018-12-11
FMI82001-10-25
GCJ72003-10-30
MMK71998-02-24
LZA62024-08-23
LZH62022-12-20
OMP62021-06-04
FOS62013-04-17
FRO62009-02-26
DQO62005-12-22
LZC52026-01-14
PIF52022-05-19
DQX52009-02-06
FPA52000-01-04
KMF51997-12-10
FMG51997-04-02
DTL51990-08-15
DWF51988-03-22
FEG42004-05-17
DYB42002-07-03
IMD41999-01-21
EZC41991-08-16
LDQ41984-02-04
PNR32024-12-19
DXN32016-10-14
HIB32012-03-23
FZP32009-09-23

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