FDA.reportPublic FDA data

REPRO-MED SYSTEMS, INC. dba KORU Medical Systems

Matched from indexed company URL: Repro-Med Systems, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
13183601318360REPRO-MED SYSTEMS, INC. dba KORU Medical Systems1N2020-04-2524 Carpenter Rd CHESTER NY US 10918

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
309761389663381K933652FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBINGFRN1994-05-18
309761270814701K894299REPRO-MED EMERGENCY AIRWAY VACUUM SYSTEMBSY1989-09-22
309761239830622K892529REPRO-MED NEONATE ASPIRATION SYSTEMBSY1989-06-12
309761347621840K853216MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4HHK1986-04-02
309761879803371K180843HIgH-Flo Super26 Subcutaneous Needle SetsFPA2019-04-04
309761471065730K162613Integrated Catch-up Freedom Syringe Driver Infusion SystemFRN2017-08-31
309761327795050K122404MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26FPA2013-05-06
309761194540536K102512RMS SUBCUTANEOUS NEEDLE SETFPA2011-05-20
309761946634569K033099ADR THINSET INFUSION SET MODEL, 23-106, 23-109, 43-106, 43-109FPA2003-10-16
309761142311345
309761418263183

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FPA42019-04-04
FRN22017-08-31
BSY21989-09-22
HHK11986-04-02

PMA#

PMN#