Rosanna Lee

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
Rosanna Lee5N2026-01-011200 Townline Rd Mundelein IL US 60060
Rosanna Lee5N2026-01-011200 Townline Rd Mundelein IL US 60060
96813853001751372Rosanna Lee1N2026-01-011200 Townline Rd MUNDELEIN IL US 60060
30041225983004122598Rosanna Lee1N2026-01-011200 Townline Rd Mundelein IL US 60060
30045858563004585856Rosanna Lee1N2026-01-011200 Townline Road Mundelein IL US 60060
30058064383005806438Rosanna Lee1N2026-01-011200 Townline Road Mundelein IL US 60060
30066369623006636962Rosanna Lee1N2026-01-011200 Townline Road Mundelein IL US 60060
30070760793007076079Rosanna Lee1N2026-01-011200 Townline Rd Mundelein IL US 60060
30070828973007082897Rosanna Lee1N2026-01-011200 Townline Rd Mundelein IL US 60060
30072894083007289408Rosanna Lee1N2026-01-011200 Townline Rd Mundelein IL US 60060
30103052753010305275Rosanna Lee1N2026-01-011200 Townline Rd Mundelein IL US 60060
30103635403010363540Rosanna Lee1N2026-01-011200 Townline Road Mundelein IL US 60060
30106104543010610454Rosanna Lee1N2026-01-011200 Townline Road Mundelein IL US 60060
30114949173011494917Rosanna Lee1N2026-01-011200 Townline Rd Mundelein IL US 60060
30118053153011805315Rosanna Lee1N2026-01-011200 Townline Rd Mundelein IL US 60060
30129906313012990631Rosanna Lee1N2026-01-011200 Townline Road Mundelein IL US 60060
30130214743013021474Rosanna Lee1N2026-01-011200 Townline Rd Mundelein IL US 60060
30149230863014923086Rosanna Lee1N2026-01-011200 Townline Road Mundelein IL US 60060
30151051293015105129Rosanna Lee1N2026-01-011200 Townline Road Mundelein IL US 60060
30151731653015173165Rosanna Lee1N2026-01-011200 Townline Road Mundelein IL US 60060
30151732123015173212Rosanna Lee1N2026-01-011200 Townline Rd Mundelein IL US 60060
30154992423015499242Rosanna Lee1N2026-01-011200 Townline Road Mundelein IL US 60060
30159168303015916830Rosanna Lee1N2026-01-011200 Townline Road Mundelein IL US 60060
30164900193016490019Rosanna Lee1N2026-01-011200 Townline Rd Mundelein IL US 60060
30170314843017031484Rosanna Lee1N2026-01-011200 Townline Road Mundelein IL US 60060

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1753801548560275K991559MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELDFXX1999-08-23
1753801009589810K990463MEDLINE EXCEL WHEELCHAIRSIOR1999-03-15
311471155731645K983187MEDSOL GOLDENBERG BONE MARROW BIOPSY NEEDLEKNW1998-12-10
1753801306180962K982694MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPESFYA1998-12-14
1753801809914216K964358AMSEAL SURGICAL FACE MASKFXX1997-02-14
311471741177181K964176TECNO REUSABLE, ELECTROSURGICAL, BIPOLAR FORCEPSGEI1997-08-14
1753801537382200K964142MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNSKKX1997-02-25
311471337640799K962826MEDLINE RADIOLOGY-DIAGNOSTIC KITSLRO1996-09-16
1753801337640799K962826MEDLINE RADIOLOGY-DIAGNOSTIC KITSLRO1996-09-16
2259571337640799K962826MEDLINE RADIOLOGY-DIAGNOSTIC KITSLRO1996-09-16
311471228839100K962205STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USEKKX1996-11-26
1753801228839100K962205STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USEKKX1996-11-26
1753801767008806K961758CARASYN HYDROGEL WOUND PRODUCTSMGQ1996-07-11
1753801497574083K953669PERSPECTIVES IMPREGNATED HYDROGEL WOUND DRESSINGMGQ1995-09-22
1753802031462412K953418ELECTROCAUTERY SHROUDGCJ1995-10-07
311471844805001K942571HYPER-INFLATION BAGNHK1994-06-10
1753801220081613K940555SANDOZ NUTRITION COMPAT ENTERAL FEED PUMP W/HYDRATIONLZH1995-02-01
1753801835835179K936304ELECTROSURGICAL PENCILGEI1994-06-13
311471808492981K935170CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONSDQX1994-03-31
311471408349109K932654ELECTROSURGIAL INSTRUMENTSGEI1994-02-22
2259571408349109K932654ELECTROSURGIAL INSTRUMENTSGEI1994-02-22
311471668467939K925591MERIDIAN MEDICAL SYSTEMS HYPER INFLATION BAY SYSTBZR1993-09-16
311471411458861K925217MERIDIAN MEDICAL SYSTEMS BREATHING FILTERCAH1993-01-26
1753801411458861K925217MERIDIAN MEDICAL SYSTEMS BREATHING FILTERCAH1993-01-26
1753801444965331K914118I.C. MEDICAL AUTO INTRA-ABDOMINAL PLUME ELIMINATORFYD1992-02-12
311471856109143K903493NAMIC CONTRAST SAVINGS DELIVERY SYSTEMIZI1991-03-26
1753801856109143K903493NAMIC CONTRAST SAVINGS DELIVERY SYSTEMIZI1991-03-26
1753801509717942K891575COMPAT ENTERAL FEED PUMP 199235 & 199240LZH1989-09-12
1753802071506512K873955NAMIC ANGIOGRAPHIC SYRINGEDXT1988-02-05
1753801007773174K872165ELASTO-GEL OCCLUSIVE DRESSINGFRO1987-06-26
1753801061760368K854215DYNAFEEDKNT1985-12-02
311471820030936K852140NAMIC CONTRAST & FLUID DELIVERY SPIKES(VARIOUS)FPA1985-05-30
1753801769634417K850959EQUIPMENT SNAP KOVERSJAA1985-04-09
311471569487055K843726NAMIC ADB ANGIOGRAPHIC DUMP BAGDQO1984-10-18
311471237950995K831974STOMACH TUBE LEVIN TUBEKNT1983-07-18
1753801237950995K831974STOMACH TUBE LEVIN TUBEKNT1983-07-18
1753801327146478K822100HIGH PRESSURE CONTRAST INJECTION LINEDQO1982-08-24
311471858037780K821970DYNACOR URETHRAL CATHETER TRAYKOD1982-07-21
1753801858037780K821970DYNACOR URETHRAL CATHETER TRAYKOD1982-07-21
1753801113721935K820355DISPOSABLE DIAPHRAGM DOMESDRS1982-03-04
311471613593848K810156ARGYLE SALEM SUMP TUBEKNT1981-03-02
1753801613593848K810156ARGYLE SALEM SUMP TUBEKNT1981-03-02
311471080653290K782095STOPCOCKS, MANIFOLDSDTL1979-01-23
1753801080653290K782095STOPCOCKS, MANIFOLDSDTL1979-01-23
311471303436952K770977CARDIOVASCULAR SPRING GUIDESDQX1977-06-14
1753801554149066K232230YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F 20 NDE; YJ-K1F 20 NDS; YJ-K1F 18 NDEE; YJ-K1F 16 VDE; YJ-K1F 16 VDS; YJ-K1F 18 VDE; YJ-K1F 18 VDS; YJ-K1F 20 VDE; YJ-K1F 20 VDS; YJ-K2 16 VDFE; YJ-K2 16 VDFS; YJ-K2 18 VDFE; YJ-K2 18 VDFS; YJ-K2 20 VDFE; YJ-K2 20 VDFS; YJ-K1G 18 NFFE; YJ-K1G 18 NFFS; YJ-K2TC 16 NAFE; YJ-K2TC 18 NAFE; YJ-K2TC 20 NAFE)IOR2023-10-03
1534202065529888K221278Transducer Probe CoverITX2023-01-11
1753801570094928K220365Gemini Sterilization WrapFRG2022-10-06
1753801656590198K202668Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm2 per Glove of Extractable ProteinKGO2020-12-19
1753801278512692K193217SensiCare PI and SensiCare PI Micro Surgical GlovesKGO2020-04-06
1753801123173626K192988Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for UseKGO2020-04-01
1753801511617478K192820SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs)KGO2020-02-28
1753801300527836K191915SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe VKGO2020-03-06
3180161341077105K1913780.9% Sodium Chloride Injection, USP, Pre-filled COP SyringeNGT2019-09-15
1753802063348723K190950Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced)FYA2019-07-04
311471830242127K182812Medline Cautery Electrode (SILICONE)GEI2018-12-12
311471000074754K173889Medline Cautery Electrode (PTFE)GEI2018-04-09
1753801323232743K151503NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBEPIF2016-04-05
311471785683821K1504773M Comply Indicator Tape for Ethylene Oxide (EO) SterilizationJOJ2015-07-02
1753801619483590K140947COMPAT ENTERAL DELIVERY PUMP SETSPIF2014-09-04
311471586838864K140482MANDREL GUIDEWIREOCY2014-04-08
311471174566305K123095MEDLINE BLOOD PRESSURE TRANSDUCERDRS2013-05-08
311472025748912K120069MEDLINE STOPCOCK AND MANIFOLDDTL2012-04-03
311471590570738K120008MEDLINE HIGH PRESSURE INJECTION TUBINGDQO2012-08-17
1753801710923356K113583CURAD ANTIBACTERIAL BANDAGEFRO2012-04-12
311471685116023K112769CURAD COMPRESSION HOSIERYDWL2012-03-01
1753801685116023K112769CURAD COMPRESSION HOSIERYDWL2012-03-01
1753801614717797K112110STERILE LUBRICATING JELLYKMJ2012-04-10
311471807199891K110977VESOFLOWJOW2011-08-25
1753801164007427K110698NUZONE X2T CHEMO, POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVES POWDER FREEKGO2011-12-07
311471335502774K100302MEDLINE PVC URETHRAL CATHETEREZD2010-07-02
311471093255354K093726MEDIGUARD NITRILE EXAMINATION GLOVE- BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)LZA2010-02-22
1753801081287413K093349MEDLINE CURAD WOUND DRESSINGSFRO2010-01-07
1753801478139681K092981PANPAC VAGINAL PESSARYHHW2010-07-22
1753801844353407K091652NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGSLZA2009-09-04
311472037144045K090568MEDLINE NITRILE EXAM GLOVES W/ALOE -GREENLZA2009-10-02
1753801713879543K082815WELL LEAD SILICONE AND LATEX FOLEY CATHETERSEZL2008-10-08
1753801581204647K082784JUMAO MANUAL WHEELCHAIRIOR2008-10-07
1753801020390385K081791E-Z CLEAN ELECTROSURGICAL ELECTRODEGEI2008-10-21
311471746089630K080144MANDREL GUIDEWIRES OR M-WIRESDQX2008-02-26
1753801304439322K073718MEDLINE GASTROSTOMY TUBEKGC2008-03-19
1753801043565100K071423MEDLINE LATEX FOLEY CATHETEREZL2007-07-18
311471905519078K070150VASCUPUNCTURE PICC GUIDEWIREDQX2007-02-15
1753801369267962K063213EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVESLYZ2006-12-05
1753801568137202K061716PRESTIGE AMERITECH FACE MASKFXX2006-08-14
311471076931917K052168MEDLINE SILVERTOUCH 100% SILICONE FOLEY CATHETER, MODEL MEDLINE INDUSTRIES, INC.EZL2006-02-16
1753801076931917K052168MEDLINE SILVERTOUCH 100% SILICONE FOLEY CATHETER, MODEL MEDLINE INDUSTRIES, INC.EZL2006-02-16
1753801190804318K051082MEDTRADE PRODUCTS SKIN PROTECTIVE BARRIER WIPE (STERILE AND PRESERVED)KMF2005-11-08
1753801774270600K042683WELL LEAD ENDOTRACHEAL TUBEBTR2005-02-18
1753801038688900K041316ANTIMICROBIAL ALGINATE DRESSINGFRO2004-08-05
311471336910617K041060E-Z LUBRICATING JELLYKMJ2004-05-07
1753801667247885K040517TENDERWET ACTIVEMGQ2004-03-25
311471124569321K040052FINE SURGICAL CIRCUMCISION CLAMPHFX2004-04-09
1753801141463966K033732MEDTRADE PRODUCTS ANTISEPTIC BARRIER SILVER FOAM DRESSING, MODEL 09912450FRO2004-12-01
1753801422830819K032464ALOETOUCH POWDER FREE LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING CLAIM (50KGO2003-08-22
1753801869310703K032065MEDLINE BAND BAGS AND EQUIPMENT COVERSMMP2003-09-22
311471689511480K031652VASCUPUNCTURE PICC GUIDEWIREDQX2003-09-30
1753801246292752K023755WINNER EAR LOOP PROCEDURE MASK, TIE-ON SURGICAL MASK & EAR LOOP PROCEDURE MASK WITH SHIELDFXX2003-06-10
311471049682243K022895ELCAM STOPCOCKS AND MANIFOLDSFMG2002-10-18
1753801537746848K022442POWDER FREE GREEN LATEX SURGICAL GLOVES, STERILE WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM LESS)KGO2002-09-05
311471308868253K021990GALT MEDICAL GUIDEWIREDQX2002-07-18
1753801077106780K012186MASTER & FRANK SURGICAL GOWNS (STERILE)FYA2001-12-07
1753801681734567K012116ACRYDERM SILVER ANTIMICROBIAL PERFORATED WOUND DRESSINGFRO2001-09-12
1753801842839616K003755MEDLINE BLOCKADE OR RESISTAT SURGICAL GOWNS AND SURGGICAL DRAPESFYA2001-02-16
311471760198016K003353MEDLINE ALOE TOUCH STERILE NITRILE EXAMINATION GLOVES WITH ALOE VERALZA2000-11-22
311471304882737K003091MEDLINE STERILE VINYL EXAM GLOVES, POWDER FREE, YELLOWLYZ2000-10-24
1753801872664170K002968MEDLINE STERILIZATION WRAPFRG2001-01-23
1753801559299448K001649STERITEC AUTOCLAVE TAPES, MODEL CI122 & CI1234JOJ2000-06-23
311471427211471BK920003
311471004722420
2259571004722420
311471008964545
2259571008964545
311471024745203
2259571024745203
311471030524608

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KGO82020-12-19
GEI82018-12-12
FRO62012-04-12
DQX62008-02-26
KNT51985-12-02
FYA42019-07-04
LZA42010-02-22
EZL42008-10-08
FXX42006-08-14
IOR32023-10-03
DQO32012-08-17
DTL32012-04-03
MGQ32004-03-25
KKX31997-02-25
LRO31996-09-16
CAH31993-01-26
FRG22022-10-06
PIF22016-04-05
JOJ22015-07-02
DRS22013-05-08
KMJ22012-04-10
DWL22012-03-01
EZD22010-07-02
LYZ22006-12-05
LZH21995-02-01
BZR21993-09-16
IZI21991-03-26
KOD21982-07-21
ITX12023-01-11
NGT12019-09-15
OCY12014-04-08
JOW12011-08-25
HHW12010-07-22
KGC12008-03-19
KMF12005-11-08
BTR12005-02-18
HFX12004-04-09
MMP12003-09-22
FMG12002-10-18
KNW11998-12-10