FDA.reportPublic FDA data

KAWASUMI LABORATORIES AMERICA, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10559271000113359KAWASUMI LABORATORIES AMERICA, INC.1Y2026-01-0110002 PRINCESS PALM AVENUE, SUITE 324 Tampa FL US 33619

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
108891358559159K994323KAWASUMI LABORATORIES PHILEBOTOMY SETLHI2000-03-08
108891638385694K935505WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTERFMI1994-02-03
108891035545067K923323INTERMITTENT INJECTION SITEFOZ1993-07-13
108891593096032K921901PORT ACCESS INFUSION SETFRN1993-09-10
108891376223011K896896KAWASUMI SMALL VEIN INFUSION SETFPA1990-09-12
108891720185059K252355K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingPTI2025-11-26
108891862069581K230408K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)JKA2023-06-01
108891871912550K223810Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)JKA2023-02-24
108891444758159K190485Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)JKA2019-07-08
108891075830770K190233K-Shield Advantage Port Access Infusion Set (PAIS)FPA2019-05-02
108891939933255K172957Kawasumi Laboratories Blood Drawing Kit (BDK) SystemKSB2018-09-28
108891346049834K102994K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTORFMI2010-11-03
108891243239768K102890K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER)FPA2010-10-21
108891583854128K100720K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBINGFPA2010-11-18
108891845727357K060580K-SHIELD PORT ACCESS INFUSION SETFPA2006-06-06
108891671657474K030385IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTORFPA2003-04-15
108891928846851K023917WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTORFPA2003-02-26
108891450718192K001426KAWASUMI LABORATORIES IV ADMINISTRATION SET WITH FILTERFPA2000-07-21
108892036604349K001424KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARDFPA2000-07-21
108891726835208K001423KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARYFPA2000-07-21

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FPA102019-05-02
JKA32023-06-01
FMI22010-11-03
PTI12025-11-26
KSB12018-09-28
LHI12000-03-08
FRN11993-09-10
FOZ11993-07-13

PMN#