Rosanna Lee

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
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
30174068403017406840Rosanna 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
311471537382200K964142MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNSKKX1997-02-25
1753801537382200K964142MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNSKKX1997-02-25
2259571537382200K964142MEDLINE 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
2259571828023355K960858GREINER VACUTTE BLOOD COLLECTION TUBE W/ CLOT ACTIVATOR & GEL SEPARATORJKA1996-08-30
1753801497574083K953669PERSPECTIVES IMPREGNATED HYDROGEL WOUND DRESSINGMGQ1995-09-22
1753802031462412K953418ELECTROCAUTERY SHROUDGCJ1995-10-07
311471500525763K946283COPAN VENTURI TRANSYSTEM LIQUID STUARTS MEDIUMJSM1995-03-10
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
311471611522810K202449Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm² per glove of Extractable ProteinKGO2020-11-18
2259571611522810K202449Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm² per glove of Extractable ProteinKGO2020-11-18
1753801278512692K193217SensiCare PI and SensiCare PI Micro Surgical GlovesKGO2020-04-06
1753801123173626K192988Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for UseKGO2020-04-01
311471511617478K192820SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs)KGO2020-02-28
1753801511617478K192820SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs)KGO2020-02-28
311471300527836K191915SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe VKGO2020-03-06
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
311471460318586K183413TruWave Disposable Pressure TransducerDXO2019-05-01
311471830242127K182812Medline Cautery Electrode (SILICONE)GEI2018-12-12
311471000074754K173889Medline Cautery Electrode (PTFE)GEI2018-04-09
311471321611193K161779MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV CatheterFOZ2016-11-03
311471461334420K160928Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green)KGO2016-12-20
2259571461334420K160928Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green)KGO2016-12-20
1753801323232743K151503NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBEPIF2016-04-05
311471785683821K1504773M Comply Indicator Tape for Ethylene Oxide (EO) SterilizationJOJ2015-07-02
311471247767924K142941Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color.KGO2015-11-02
2259571247767924K142941Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color.KGO2015-11-02
1753801619483590K140947COMPAT ENTERAL DELIVERY PUMP SETSPIF2014-09-04
311471586838864K140482MANDREL GUIDEWIREOCY2014-04-08
311471174566305K123095MEDLINE BLOOD PRESSURE TRANSDUCERDRS2013-05-08
311471462722673K120930CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL FOAM PATCH, CHG PATCH, CHG DRESSINGFRO2012-10-26
2259571741600565K120743SPECULUM, VAGINAL, NONMETALHIB2012-03-23
311472025748912K120069MEDLINE STOPCOCK AND MANIFOLDDTL2012-04-03
311471590570738K120008MEDLINE HIGH PRESSURE INJECTION TUBINGDQO2012-08-17
1753801710923356K113583CURAD ANTIBACTERIAL BANDAGEFRO2012-04-12
311471548416444K113353GEMINI STERILZATION WRAPFRG2013-01-31
311471685116023K112769CURAD COMPRESSION HOSIERYDWL2012-03-01
1753801685116023K112769CURAD COMPRESSION HOSIERYDWL2012-03-01
2259571685116023K112769CURAD 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
311471195621198K090066POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 OF GLOVEKGO2009-05-15
2259571195621198K090066POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 OF GLOVEKGO2009-05-15
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
2259571748639507K051378POWDER-FREE BLUE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)LZA2005-08-03
1753801190804318K051082MEDTRADE PRODUCTS SKIN PROTECTIVE BARRIER WIPE (STERILE AND PRESERVED)KMF2005-11-08
2259571184575240K043017PREVENTION BREATHABLE, IMPERVIOUS SURGICAL GOWNSFYA2005-03-08
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

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KGO192020-12-19
GEI82018-12-12
FRO72012-10-26
KKX72002-05-03
DQX62008-02-26
FYA52019-07-04
LZA52010-02-22
KNT51985-12-02
EZL42008-10-08
FXX42006-08-14
IOR32023-10-03
FRG32022-10-06
DQO32012-08-17
DTL32012-04-03
DWL32012-03-01
MGQ32004-03-25
LRO31996-09-16
CAH31993-01-26
PIF22016-04-05
JOJ22015-07-02
DRS22013-05-08
KMJ22012-04-10
EZD22010-07-02
LYZ22006-12-05
MMP22003-09-22
FPA22000-09-07
LZH21995-02-01
BZR21993-09-16
IZI21991-03-26
KOD21982-07-21
ITX12023-01-11
NGT12019-09-15
DXO12019-05-01
FOZ12016-11-03
OCY12014-04-08
HIB12012-03-23
JOW12011-08-25
HHW12010-07-22
KGC12008-03-19
KMF12005-11-08