FDA.reportPublic FDA data

Chris Steinke

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80207853009291251Chris Steinke1N2026-01-0187 Venture Dr Dover NH US 03820
96124333002808464Chris Steinke1N2026-01-0187 Venture Dr Dover NH US 03820
30045691803004569180Chris Steinke1N2026-01-0187 Venture Drive Dover NH US 03820
30069425243006942524Chris Steinke1N2026-01-012750 Morris Road Suite A200 Lansdale PA US 19446
30108727923010872792Chris Steinke1N2026-01-012750 Morris Road Suite A200 Lansdale PA US 19446

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
97471086028499K993442VYGON LIFECATH-PICC (PUR) CATHETERS (SINGLE AND DOUBLE LUMEN 3FR, 4FR, 4.5FR, AND 5FR)LJS2000-08-03
97471327289455K993052VYGON 2 FR EPICUTANEO PUR-CATHETERLJS2000-08-03
97481956479709K991918NUTRISAFE EXTENSION TUBEKNT1999-10-29
97481325727741K981630VYGON DOUBLE LUMEN UMBILICAL CATHETERFOS1998-10-01
97481701307826K974806VYGON NEO-SUMPKNT1998-03-23
97481492848147K963981VYGON BIONECTOR WITH EXTENSION SETFPA1997-02-14
97481722203271K963571VYGON MULTI-DOSE VIAL ADAPTER & BIONECTORFMI1997-06-02
97481430307758K963196VYGON UMBILICAL CATHETHER INSERTION TRAYFOZ1997-09-09
97481786720733K960795VYGON DOUBLE LUMEN ENDOTRACHEAL TUBEBTR1996-05-22
97491786720733K960795VYGON DOUBLE LUMEN ENDOTRACHEAL TUBEBTR1996-05-22
97471315990829K954302VYGON PREMI-CATH - LONG TERM CATHETERLJS1996-06-17
97471387803574K954112VYGON LIFEVAC MID-LINE TRAYFOZ1996-05-09
97481555594715K941678BIONECTORFOZ1995-06-26
97481717718718K925854VYGON - ENTERAL FEEDING TUBE - POLYURETHANEKNT1994-05-02
97481432488089K921374VYGON XRO VENOUS/ARTERIAL UMBILICAL CATHETERFOS1992-10-26
97481596272302K921352VYGON POLYURETHANE VENOUS/ARTERIAL XRO UMBIL. CATHFOS1992-10-26
97482015178421K910909MUCAIDBSY1991-05-20
97492015178421K910909MUCAIDBSY1991-05-20
97481118477434K910908MUCAID WITH SUCTION CATHETER AND EXTENSION TUBINGBSY1991-05-20
97471262750805K901640MULTICATH PLACEMENT KITFOZ1990-08-10
97471760685637K897168EPICUTANEO-CAVA CATHETER CODE 2184LJS1990-04-23
97491188626363K894954.22 & 1.2 MICRON IV FILTERSFPB1989-11-13
97481134734486K883612LECTROSPIRALFPA1988-09-29
97481481017100K860285XRO GASTRO-DUODENAL, DUAL FLOW TUBE, SALEM TYPEKNT1986-02-11
97482015280839K851478VYGON SPINAL ANESTHESIA NEEDLE W/INTRODUCER 183BSP1985-05-07
97481766170935K851477VYGON EXCHANGE TRANSFUSION TRAY 275.00BRZ1985-05-03
97481506528098K851473VYGON DELEE SUCTION CATHETER CODE NO 533BSY1985-07-15
97481274448326K851005XRO UMBILICAL CATHETER-CODE 270FOS1985-05-21
97481465658377K832628VYGON THORACIC DRAINAGE-VARIOUS #'SKDD1984-01-30
97481591673568K831801HEMOCLAV VENOUS CATHETERFIQ1983-07-07
97481078243648K822879ENTERAL NUTRITION 1KNT1982-11-16
97491615917606K822836MICROFLEX-VENOFLUXFPA1982-10-15
97481006610622K820176VYGON ENTERNAL NUTRITION TUBESKNT1982-02-05
97491727805330K813373VYGON ENDOTRACHEAL TUBESBTR1981-12-22
97481662954425K813360DERMAFILE (CAT. # 38KKX1982-03-18
97481583287002K813144INTRAFLON, INTRAFLUX, INTRAVALVEDQR1981-11-27
97482031161658K813143DESILETDYB1981-11-27
97482014685865K813142LEADER-CATHDQO1981-11-27
97481879267259K813141VYGON STOPCOCKS & RAMPS(MANIFOLDS)DTL1981-11-27
97481923968803K813140VYGON EXTENSION TUBES & CONNECTORSDQO1981-11-27
97481641327647K243361NutrifitFPD2024-12-19
97481922746650K161141ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFITPNR2017-03-22
97481665955169K151237Nutrisafe 2- ENFit AdaptorPIO2016-02-09
97471716336808K141026LEADERFLEXFOZ2014-07-30
97481716336808K141026LEADERFLEXFOZ2014-07-30
835101529732871K123035SEAL ONEDXC2012-11-28
97481353250762K122834POLYSITE IMPLANTABLE INFUSION PORTSLJT2013-12-11
835101451733854K122834POLYSITE IMPLANTABLE INFUSION PORTSLJT2013-12-11
97481294375698K121105NUTRISAFE 2 FEEDING TUBEFPD2012-12-18
835101074396951K120261PPS PI PRESSURE INJECTABLE SAFETY HUBER NEEDLE WITHOUT LATERAL INJECTION SITE, PPS PI PRESSURE INJECTABLE SAFETY HUBERFPA2012-05-02
97481130666438K120261PPS PI PRESSURE INJECTABLE SAFETY HUBER NEEDLE WITHOUT LATERAL INJECTION SITE, PPS PI PRESSURE INJECTABLE SAFETY HUBERFPA2012-05-02
97481919533320K100163NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXXFPD2011-10-13
97491919533320K100163NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXXFPD2011-10-13
835101860646027K080472SEDAT MYSHELL LITEDTL2008-04-23
97481400810307K070705MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039FOZ2007-11-30
97481679962887K063631POLYPERF / POLYPERF SAFEFPA2007-10-05
835101873175726K063631POLYPERF / POLYPERF SAFEFPA2007-10-05
97471985459413K061250MULTICATH EXPERTFOZ2006-09-29
97481278045899K060944NUTRISAFE 2FPD2006-09-15
97481073653784K052881VYGON LATEX FREE BIONECTORFOZ2006-03-02
97472043978281K052564VYGON LEADER-FLEXFOZ2006-04-05
97471144806147K052475VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERSLJS2006-09-14
97471607735048K051690VYGON NUTRILINE CATHETERSLJS2005-08-19
835101724378903K042449DOLPHIN INFLATION DEVICEMAV2005-04-18
97471093816621K041468PREMICATH, 1261.205LJS2004-09-09
97481877681181K040657BOUSSIGNAC/VYGON ENDOTRACHEAL TUBE, MODEL 6501.25/30/35 AND 6502.70/75/80BTR2004-06-10
97481435191617K013884BOUSSIGNAC C.P.A.P. DEVICEBYE2003-01-21
97471030435187K010913VYGON SPLIT CANNULA INTRODUCERDYB2001-09-28
97481720717303K003311NUTRISAFE PUR ENTERAL FEEDING TUBEFPD2002-01-11
97481190304307
97481209933652
97481258302097
835101264547020
97481271233991
97481304594744
97481316010521
97481371791813
97481598237949
97481627762519
97481653908570

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FOZ142014-07-30
KNT121999-10-29
FPD102024-12-19
FPA102012-05-02
FOS81998-10-01
LJS72006-09-14
BSY71991-05-20
BTR62004-06-10
DQO41981-11-27
LJT32013-12-11
DTL32008-04-23
DYB32001-09-28
PIO22016-02-09
BYE22003-01-21
FMI21997-06-02
BSP21985-05-07
BRZ21985-05-03
KDD21984-01-30
FIQ21983-07-07
KKX21982-03-18
DQR21981-11-27
PNR12017-03-22
DXC12012-11-28
MAV12005-04-18
FPB11989-11-13