FDA.reportPublic FDA data

Deno Zachary

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80315613002807721Deno Zachary1N2026-01-01201 East 69th Street, Suite 5O, New York NY US 10021
96159083003282181Deno Zachary1N2026-01-01201 East 69th Street, Suite 5O, New York NY US 10021
10001630681000163068Deno Zachary1N2026-01-01201 East 69th Street, Suite 5O, New York NY US 10021
30046494803004649480DENO ZACHARY1N2026-01-01201 East 69th Street SUITE 5O New York NY US 10021
30082299903008229990Deno Zachary1N2026-01-01201 East 69th Street, Suite 5O, New York NY US 10021
30140552123014055212Deno Zachary1N2026-01-01201 East 69th Street, Suite 5O, New York NY US 10021

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
413951358559159K994323KAWASUMI LABORATORIES PHILEBOTOMY SETLHI2000-03-08
108881358559159K994323KAWASUMI LABORATORIES PHILEBOTOMY SETLHI2000-03-08
108881638385694K935505WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTERFMI1994-02-03
413951638385694K935505WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTERFMI1994-02-03
413951035545067K923323INTERMITTENT INJECTION SITEFOZ1993-07-13
108881035545067K923323INTERMITTENT INJECTION SITEFOZ1993-07-13
108881593096032K921901PORT ACCESS INFUSION SETFRN1993-09-10
413951593096032K921901PORT ACCESS INFUSION SETFRN1993-09-10
108881376223011K896896KAWASUMI SMALL VEIN INFUSION SETFPA1990-09-12
413951376223011K896896KAWASUMI SMALL VEIN INFUSION SETFPA1990-09-12
413951720185059K252355K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingPTI2025-11-26
108881720185059K252355K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingPTI2025-11-26
414042060209016K242176BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)KOC2025-05-15
414041203175059K242155DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)KDI2025-05-15
108881579952107K241855SB Knife Jr2 (MD-47702 and MD-47702L)KNS2025-03-26
414041189254950K231589Blood Tubing Lines for Hemodialysis AV06C-EKOC2023-07-28
413951862069581K230408K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)JKA2023-06-01
108881862069581K230408K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)JKA2023-06-01
108881871912550K223810Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)JKA2023-02-24
413951871912550K223810Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)JKA2023-02-24
108881237778325K190621SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - LongKNS2019-04-23
108881444758159K190485Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)JKA2019-07-08
413951444758159K190485Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)JKA2019-07-08
413951075830770K190233K-Shield Advantage Port Access Infusion Set (PAIS)FPA2019-05-02
108881075830770K190233K-Shield Advantage Port Access Infusion Set (PAIS)FPA2019-05-02
108881059311714K182520Flexible OvertubeFED2019-05-15
108881565243752K173004SB Soft Hood - Straight type, SB Soft Hood - Undercut typeFDS2018-05-08
413951939933255K172957Kawasumi Laboratories Blood Drawing Kit (BDK) SystemKSB2018-09-28
108881939933255K172957Kawasumi Laboratories Blood Drawing Kit (BDK) SystemKSB2018-09-28
414041414943394K152938DBB-06 Hemodialysis Delivery SystemKDI2016-03-18
413951404823048K134019MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTOFIE2014-09-11
108881346049834K102994K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTORFMI2010-11-03
413951346049834K102994K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTORFMI2010-11-03
108881243239768K102890K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER)FPA2010-10-21
413951243239768K102890K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER)FPA2010-10-21
108881583854128K100720K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBINGFPA2010-11-18
413951583854128K100720K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBINGFPA2010-11-18
414041867249476K091978DBB-06 HEMODIALYSIS DELIVERY SYSTEMKDI2010-03-25
1238001737226105K082719NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-PKOC2009-03-30
414041260999218K061519MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEMKDI2007-09-28
108881845727357K060580K-SHIELD PORT ACCESS INFUSION SETFPA2006-06-06
413951845727357K060580K-SHIELD PORT ACCESS INFUSION SETFPA2006-06-06
108881671657474K030385IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTORFPA2003-04-15
413951671657474K030385IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTORFPA2003-04-15
413951928846851K023917WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTORFPA2003-02-26
108881928846851K023917WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTORFPA2003-02-26
414041425988867K023509DBB-05 HEMODIALYSIS DELIVERY SYSTEMKDI2003-10-30
108881450718192K001426KAWASUMI LABORATORIES IV ADMINISTRATION SET WITH FILTERFPA2000-07-21
413951450718192K001426KAWASUMI LABORATORIES IV ADMINISTRATION SET WITH FILTERFPA2000-07-21
108882036604349K001424KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARDFPA2000-07-21
413952036604349K001424KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARDFPA2000-07-21
413951726835208K001423KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARYFPA2000-07-21
108881726835208K001423KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARYFPA2000-07-21
127001132991501
1238001194600157
414041194600157
1238001203175059
413951215125486
414041227845559
1238001227845559
108881382254217
413951400353270
413951409846132
1238001414943394
3132791670291144
3132791702795817
413951743254645
1238001778424337
414041778424337
3132791951362326

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FPA232019-05-02
JKA62023-06-01
KDI52025-05-15
FMI42010-11-03
KOC32025-05-15
KSB32018-09-28
PTI22025-11-26
KNS22025-03-26
LHI22000-03-08
FRN21993-09-10
FOZ21993-07-13
FED12019-05-15
FDS12018-05-08
FIE12014-09-11