Rosanna Lee

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96813853001751372Rosanna Lee1N2027-01-011200 Townline Rd MUNDELEIN IL US 60060
30016505353001650535Rosanna Lee1N2027-01-011200 Townline Rd MUNDELEIN IL US 60060
30061164683006116468Rosanna Lee1N2027-01-011200 Townline Rd Mundelein IL US 60060
30066369623006636962Rosanna Lee1N2027-01-011200 Townline Road Mundelein IL US 60060
30070828913007082891Rosanna Lee1N2027-01-011200 Townline Road Mundelein IL US 60060
30070828973007082897Rosanna Lee1N2027-01-011200 Townline Rd Mundelein IL US 60060
30089621613008962161Rosanna Lee1N2027-01-011200 Townline Road Mundelein IL US 60060
30103635403010363540Rosanna Lee1N2027-01-011200 Townline Road Mundelein IL US 60060
30103989273010398927Rosanna Lee1N2027-01-011200 Townline Road -- Mundelein IL US 60060
30107963963010796396Rosanna Lee1N2027-01-011200 Townline Rd Mundelein IL US 60060
30114949173011494917Rosanna Lee1N2027-01-011200 Townline Rd Mundelein IL US 60060
30117159783011715978Rosanna Lee1N2027-01-011200 Townline Road Mundelein IL US 60060
30118053153011805315Rosanna Lee1N2027-01-011200 Townline Rd Mundelein IL US 60060
30124782803012478280Rosanna Lee1N2027-01-011200 Townline Rd Mundelein IL US 60060
30129906313012990631Rosanna Lee1N2027-01-011200 Townline Road Mundelein IL US 60060
30135484733013548473Rosanna Lee1N2027-01-011200 Townline Rd Mundelein IL US 60060
30151051293015105129Rosanna Lee1N2027-01-011200 Townline Road Mundelein IL US 60060
30167613723016761372Rosanna Lee1N2027-01-011200 Townline Rd Mundelein IL US 60060
30174068403017406840Rosanna Lee1N2027-01-011200 Townline Road Mundelein IL US 60060
30262229383026222938Rosanna Lee1N2027-01-011200 Townline Road Mundelein IL US 60060
30368305033036830503Rosanna Lee1N2027-01-011200 Townline Rd Mundelein IL US 60060
30381310223038131022Rosanna Lee1N2027-01-011200 Townline Rd Mundelein IL US 60060
30381310233038131023Rosanna Lee1N2027-01-011200 Townline Rd Mundelein IL US 60060
30381626483038162648Rosanna Lee1N2027-01-011200 Townline Rd Mundelein IL US 60060
30386137903038613790Rosanna Lee1N2027-01-011200 Townline Rd Mundelein IL US 60060

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2819431969249120K992363SURESKIN II STANDARD, SURESKIN II BORDER, SURESKIN II THINFRO1999-08-12
2819431548560275K991559MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELDFXX1999-08-23
3333801169448680K990912MTP EXTRACTION BAGGCJ1999-06-09
2819431449574666K982465DEROYAL INDUSTRIES, INC. DEFOGGEROCT1998-08-11
197861865553217K980005MANAN D BAGEXF1998-01-30
2819431374172959K970946MEDLINE Y-TYPE TUR/BLADDER IRRIGATION SETLJH1997-06-10
2057941299118370K964142MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNSKKX1997-02-25
2819431537382200K964142MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNSKKX1997-02-25
2819431337640799K962826MEDLINE RADIOLOGY-DIAGNOSTIC KITSLRO1996-09-16
2819432031462412K953418ELECTROCAUTERY SHROUDGCJ1995-10-07
2819431470331422K953107ANESTHESIA/RESPIRATORY FACE MASKBSJ1995-08-15
2819431756865024K951802SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KITDXT1995-07-21
2819431699744300K951722PERCEPTOR COMPENSATOR MORSE MANIFOLDDRS1996-03-25
2819431835835179K936304ELECTROSURGICAL PENCILGEI1994-06-13
2819431411458861K925217MERIDIAN MEDICAL SYSTEMS BREATHING FILTERCAH1993-01-26
2819431341225522K925167MASS SPECTROMETRY MONITORING LINE CONONECTORSCCK1993-01-22
2819431786112190K922410SCIMED AVENUE CORONARY GUIDEWIRE INSERTION TOOLDQX1992-07-23
3333801795763841K921695ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERSITX1995-02-23
2819431444965331K914118I.C. MEDICAL AUTO INTRA-ABDOMINAL PLUME ELIMINATORFYD1992-02-12
2819431458429210K912975OPERAND LUBRICATING JELLYKMJ1991-09-27
2819432040362720K912132OPERAND LUBRICATING JELLYFHX1991-08-07
2819431420252931K910944MEDIFILKGN1991-04-02
2819431868136624K910764THE PERCEPTOR(TM) STAND ALONE TRANSDUCERDRS1991-04-22
197861682868386K904994CLOSED SYSTEM FLUSH SETDXT1991-01-15
2819431294978461K903606GUIDEWIRE TORQUE DEVICE AND GUIDEWIRE INTRODUCERLIT1990-09-27
2819431856109143K903493NAMIC CONTRAST SAVINGS DELIVERY SYSTEMIZI1991-03-26
2819431009445154K902472MORSE DT MANIFOLDDRS1990-08-23
2819431824137242K900783MDI ADAPTORCAF1990-07-18
2819431020143902K900652NAMIC PTCA Y-ADAPTORDTL1990-06-26
2819431043443632K896108THE PILOT SCIMED TORQUE DEVICELOX1990-01-09
2819431613668369K896087PALESTRANT IRRIGATION AND DRAINAGE SETKGZ1989-11-03
2819431992124579K884408NAMIC DUAL BACKCHECK VALVEDTL1989-01-12
2819432071506512K873955NAMIC ANGIOGRAPHIC SYRINGEDXT1988-02-05
2819431814086344K871157C.P.A.P. NASAL CANNULABZD1987-04-21
2819431820030936K852140NAMIC CONTRAST & FLUID DELIVERY SPIKES(VARIOUS)FPA1985-05-30
2819431703549780K851834MANAN GWI GUIDE WIRE INTRODUCERDWS1985-07-11
2819431211358638K850898MEDI-TRACE DISPOSABLE PRESSURE TRANSDUCERDRS1985-07-25
2819431569487055K843726NAMIC ADB ANGIOGRAPHIC DUMP BAGDQO1984-10-18
2819431341482310K842829HIGH PRESSURE, 1 & 3 WAY STERILE DISPOSDTL1984-10-18
2819431327146478K822100HIGH PRESSURE CONTRAST INJECTION LINEDQO1982-08-24
2819431278351208K790082ARTERIAL EXTENSION SETDQO1979-01-25
2819431080653290K782095STOPCOCKS, MANIFOLDSDTL1979-01-23
2819431178973917K232957Sterile and Non-Sterile Ultrasound GelsMUI2023-12-15
2819431236589041K223236Medline Surgical Face Mask and Medline Procedural Face MaskFXX2023-03-24
2819432033383900K221278Transducer Probe CoverITX2023-01-11
2819431570094928K220365Gemini Sterilization WrapFRG2022-10-06
2819431797237996K193621Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318)FLL2020-11-23
2819431183190842K193555Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl CitrateLZC2020-06-04
2819431511617478K192820SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs)KGO2020-02-28
2057941851018677K192194TotalShield II Surgical Helmet SystemFYA2019-10-15
2819431212561040K191759Medline Quick Switch Valve with ENFit ConnectorPIF2019-12-04
2819432063348723K190950Medline 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
2819431943128152K190643Medline Electrocautery PencilGEI2019-05-06
2819431336537969K190224Medline Burn and Wound Dressing (OTC)FRO2019-03-08
2819431783956419K183577Medline Quick-Clear WandKNT2019-05-04
2819431886055192K183431Medline Digital Rectal Thermometer SheathFLL2019-06-14
2819431075815436K183335Medline Poly-Cath Red Polymer Urethral CatheterGBM2019-06-12
2819431663244919K182828Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture PasserNLM2019-04-15
2819431830242127K182812Medline Cautery Electrode (SILICONE)GEI2018-12-12
2819431819580742K182172Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora)FYA2019-04-24
2819432070604660K181820Medline Unite Mini Plates and ScrewsHRS2018-11-01
2819431394312230K181782Medline Reinforced Epidural CatheterBSO2019-03-04
2819431268318316K181738Medline ReNewal Reprocessed OxiMax Pulse Oximetry SensorsDQA2019-03-22
2819431335582062K181726Medline Patient Cables and Lead WiresDSA2018-09-20
2819432045748230K173911Medline Burn and Wound DressingFRO2018-07-19
2819431000074754K173889Medline Cautery Electrode (PTFE)GEI2018-04-09
2819431304682736K1733480.9% Sodium Chloride Injection, USPNGT2018-06-21
2819431988213070K173276Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USPFRO2018-07-02
2819431616710438K173113Medline Disposable Electronic Thermometer Probe CoverFLL2018-01-17
2819431741155862K172954Medline Prevention CoolZone GownFYA2018-06-15
2819431979950216K172570ALGS6 Ag Alginate Wound DressingFRO2018-05-11
2819431120844747K172541Medline Catheter Specimen CollectorEZD2018-02-22
2819431394099920K170782Medline UNITEĀ® Snap-Off ScrewsHWC2017-08-18
2819431503528182K170415Medline Hemo-Force DVT Compression SleeveJOW2017-09-08
2819431733660467K163141NAMIC ClearaCIL Contrast Injection LinesDQO2017-01-06
2819431648592052K162993Gemini Sterilization WrapFRG2017-06-23
2819431381335131K162829Medline UNITEĀ® Ankle Fracture Plating SystemHRS2016-12-09
2819431947190079K161560Fingertip Pulse Oximeter MD300CN310DQA2016-10-05
2819431275605201K161473Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr)LZA2016-10-19
2819431211142830K161035Medline Singe Patient Use Blood Pressure CuffDXQ2016-06-13
2819431603716302K160318PlasmaFlowJOW2016-04-01
2819431470927098K150973NUZONE X2G Polychloroprene Synthetic Green Surgical Gloves Powder Free, Tested for Use with Chemotherapy DrugsKGO2015-08-04
2819431203094067K150286Medline Enteral Feeding SetsPIF2015-04-27
2819431701249200K150238SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical glove, With Aloe Vera (Tested of Use with Chemotherapy Drugs) -Natural ColorKGO2015-11-27
2819431431452471K141660NAWALUTION SKIN AND WOUND CLEANSERFRO2014-10-31
2819431187280065K141353HUDSON RCI AQUAPAK HUMIDIFIER ADAPTORBTT2014-08-01
2819431594096541K141064VESOFLOW PLUS DVT COMPRESSION DEVICEJOW2014-12-04
2819431812510244K140369MEDLINE NEURO SPONGEHBA2014-09-26
2819432032679896K140194NAMIC RCS SYRINGEFMF2014-04-14
2819431505837546K133934MANUKA FOAM HC, MANUKA FOAM HC (WITH ACRYLIC ADHESIVE BORDER), MANUKA FOAM HC (WITH SILICONE ADHESIVE BORDER)FRO2014-05-02
2819431640871436K133624COMPASS CT, COMPASS CT PORTDRS2014-04-18
2819431797503396K133443MARATHON NO STING LIQUID SKIN PROTECTANTKMF2014-07-10
2819431650941268K132767MEDLINE SHARPS CONTAINERMMK2014-02-03
2819431563725557K130951SIMKPN2013-08-22
197862018590057K130231NON-CONTACT INFRARED THERMOMETERFLL2013-10-15
2819431462722673K120930CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL FOAM PATCH, CHG PATCH, CHG DRESSINGFRO2012-10-26
2819431548416444K113353GEMINI STERILZATION WRAPFRG2013-01-31
2819432060325772K113198NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 MLDXT2011-11-28
2819431255718658K112203COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSISTDRS2011-12-14
2819431807199891K110977VESOFLOWJOW2011-08-25
2819431164007427K110698NUZONE X2T CHEMO, POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVES POWDER FREEKGO2011-12-07
2819431697064733K103713ELTA WOUND CLEANSERFRO2011-06-16
197861253641677K101577MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIESDQA2010-12-02
2819431312014727K100603RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)LZA2010-07-16
2819431350934514K100446CIRCUFLOW 5100 SEQUENTIAL COMPRESSION DEVICEJOW2010-03-05
2819431335502774K100302MEDLINE PVC URETHRAL CATHETEREZD2010-07-02
2819431081287413K093349MEDLINE CURAD WOUND DRESSINGSFRO2010-01-07
2819431178083581K092824N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695MSH2009-10-21
2819431000210010K092250MEDLINE RED RUBBER URETHRAL CATHETEREYB2010-01-21
3378561127509804K091272BESMED JET NEBULIZER BOTTLE SETCAF2009-11-10
2819431713879543K082815WELL LEAD SILICONE AND LATEX FOLEY CATHETERSEZL2008-10-08
2819431179033082K080976NEXUS I.V. FLUID TRANSFER DEVICELHI2008-11-10
2819431126422337K080779IRRISEPT WOUND CLEANSING SYSTEMFQH2009-02-04
2819431788331176K071552PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSINGFRO2008-04-25
2819431811456344K071244MEDLINE SINGLE PATIENT USE BLOOD PRESSURE CUFFDXQ2008-03-05
2819431388120301K070619POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELINGKGO2007-06-27
2819431418254840K070581SILVER ALGINATE II WOUND DRESSINGFRO2007-07-13
2819431735099825K070428MEDICOM SELF-SEALING STERILIZATION POUCHKCT2007-07-17
2819431748786748K063813VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULACCK2008-03-26

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FRO162019-03-08
FYA82019-10-15
KGO62020-02-28
JOW62017-09-08
DRS62014-04-18
FRG52022-10-06
GEI52019-05-06
FLL42020-11-23
DQO42017-01-06
DXT42011-11-28
DTL41990-06-26
DQA32019-03-22
LZA32016-10-19
FXX22023-03-24
ITX22023-01-11
PIF22019-12-04
HRS22018-11-01
EZD22018-02-22
DXQ22016-06-13
CAF22009-11-10
MSH22009-10-21
CCK22008-03-26
KGN22006-06-19
GCJ21999-06-09
KKX21997-02-25
MUI12023-12-15
LZC12020-06-04
GBM12019-06-12
KNT12019-05-04
NLM12019-04-15
BSO12019-03-04
DSA12018-09-20
NGT12018-06-21
HWC12017-08-18
HBA12014-09-26
BTT12014-08-01
KMF12014-07-10
FMF12014-04-14
MMK12014-02-03
KPN12013-08-22