FDA.reportPublic FDA data

BAXTER S.A. DE C.V.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80306396898BAXTER S.A. DE C.V.1N2026-01-01AV. DE LOS 50 METROS NO. 2 CIVAC, JIUTEPEC, MORELOS MX 62578

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3337101934156211K162887PrismaSATEKPO2017-01-06
3337101853369401K152129FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine SolutionKDJ2015-10-29
3337101142140372K130039REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZERKDI2013-05-02
3337101167149329K072908PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPYKPO2008-02-04
3337101194683297K070414GAMBRO CARTRIDGE BLOOD SETSFJK2007-10-12
3337102071852981K043342POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LRFJI2005-05-27

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KPO22017-01-06
KDJ12015-10-29
KDI12013-05-02
FJK12007-10-12
FJI12005-05-27